Rejuvenate Total Hip System Surgical Protocol

Rejuvenate Total Hip System
Surgical Protocol
Rejuvenate Modular Hip Stem
• Enhanced Stability1
• Proven Modularity2
• Intraoperative Flexibility
Rejuvenate
Total Hip System
Surgical Protocol
Table of Contents
Indications, Contraindications, & Precautions .............................. 1
System Overview .............................................................................. 1
Preoperative Planning and X-Ray Evaluation ................................ 2
Identifying the Proximal Femoral Shaft Axis .................................. 2
Step 1 – Femoral Neck Resection...................................................... 2
Step 7 – Trial Reduction Off Stem .................................................. 9
Modular Stem Option Only .................................................... 9-11
Step 8 – Neck and Head Implantation .......................................... 12
Step 2 – Preparing The Femoral Canal ...................................... 3-4
Appendix C – Modular Instrument Component Diagram ...... 14
Step 3 – Broaching the Femur............................................................ 5
Appendix D – Implant Catalog Numbers and Stem Lengths .... 15
Step 4 – Calcar Planing .................................................................... 6
Step 5 – Trial Reduction Off Broach .............................................. 6
Monolithic Stem Option ................................................................ 6
Modular Stem Option ...................................................................... 7
Appendix E – Offset Chart and Acceptable Head/Neck
Combination Tables ................................................ 16
Step 6 – Stem Implantation ................................................................ 8
Appendix H – Component Compatibility .................................... 20
Appendix A – Options: Modular Neck Extraction .................... 14
Appendix B – Options: Stem Extraction ...................................... 14
Appendix F – Instrument Catalog Numbers .............................. 17
Appendix G – Neck Implant Decision Algorithm ...................... 19
Surgeon Contributors:
William N. Capello, M.D.
Indiana University School of Medicine
Indianapolis, IN
Joseph J. Jankiewicz, M.D.
Sharps-Reely Hospital
San Diego, CA
Lawrence G. Morawa, M.D.
Oakwood Hospital
Dearborn, MI
James P. Crutcher, M.D.
Swedish Medical Center
Seattle, WA
James Kudrna, M.D., PhD
University of Chicago
Pritzker School of Medicine
Chicago, IL
Joseph P. Nessler, M.D.
St. Cloud Hospital
St. Cloud, MN
James A. D’Antonio, M.D.
University of Pittsburgh
Pittsburgh, PA,
Graham N. Gitlin, M.D.
Cedars Sinai Medical Center
Los Angeles, CA
Kenneth A. Greene, M.D.
Northeastern Ohio University
College of Medicine
Rootstown, OH
Michael A. Masini, M.D.
St. Joseph Mercy Hospital
Ann Arbor, MI
Joseph C. McCarthy, M.D.
Massachusetts General Hospital
Boston, MA
Phillip O. Merritt, M.D.
Glendale Adventist Medical Center
Glendale, CA
James Scott, M.D.
Tifton General Hospital
Tifton, GA
Brett R. Smith, M.D.
Allegheny General Hospital
Pittsburgh, PA
Daniel Ward, M.D.
New England Baptist Hospital
Chestnut Hill, MA
This publication sets forth detailed recommended procedures for using Stryker® Orthopaedics devices and instruments. It offers guidance that you should heed, but,
as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required.
Preoperative Templating
The Rejuvenate Femoral Platform includes a complete set of both
acetate (120% magnification) and digital femoral templates.
Acetabular Options
Conditions presenting increased risk of failure include:
1)uncooperative patient or patient with neurologic disorders,
incapable of following instructions;
Stryker offers a wide variety of acetabular components that are
compatible with the Rejuvenate Total Hip System. The surgeon
should refer to the specific acetabular component’s surgical technique for a discussion of acetabular surgical procedures.
2)osteoporosis;
Surgical Approaches
Patients should be warned of these contraindications and risks.
Each surgeon should use the surgical approach for total hip
arthroplasty with which he or she is most familiar. Patient positioning, prepping and draping, the skin incision, soft tissue
dissection, and hip dislocation are performed according to the
surgeon’s preferred technique, making certain to adequately
expose the acetabulum and the proximal femur. The Rejuvenate
Total Hip System accommodates most well-established surgical
approaches.
See the package insert for warnings, precautions, adverse effects
and other essential product information.
Indications
The indications for use of total hip replacement prostheses
include:
1)noninflammatory degenerative joint disease including
osteoarthritis and avascular necrosis;
2)rheumatoid arthritis
3)correction of functional deformity;
4)revision procedures where other treatments or devices have
failed; and,
5)treatment of nonunion, femoral neck and trochanteric
fractures of the proximal femur with head involvement that
are unmanageable using other techniques.
6)Stryker’s REJUVENATE Modular Hip System is intended
for cementless use only.
Contraindications
3)metabolic disorders which may impair bone formation; and,
4)osteomalacia.
System Overview
The Rejuvenate Femoral Platform is a modular primary hip
system of femoral stems and necks that provide surgeons with
options for personalizing the implant to each patient’s anatomy
and biomechanical needs. The fixation philosophy is built upon
the clinically successful Stryker hip stems. The Rejuvenate
femoral stem represents the latest evolution in the OmniFit and
Secur-Fit product lines, which has a successful published clinical
history.3
The Rejuvenate stem bodies are made of TMZF alloy, a proprietary Stryker material with a plasma sprayed coating of
commercially pure (CP) titanium and PureFix HA. The modular
necks are made of CoCr alloy.
The Rejuvenate femoral instrumentation consists of unique hip
instruments. The design of the Rejuvenate instrumentation incorporates suggestions and feedback from an esteemed panel of
orthopaedic surgeons, as well as key staff members from the
operating room (OR) and central supply.
The broach contours the proximal femur to the geometry of the
stem to provide a complimentary fit of the stem to the bone. The
broaches are designed with a series of teeth that are intended to
seat against highly densified cancellous bone for the interference
press-fit in the uncemented application.
Absolute contraindications include:
1)overt infection;
2)distant foci of infections (which may cause hematogenous
spread to the implant site);
3)rapid disease progression as manifested by joint destruction
or bone absorption apparent on roentgenogram;
4)skeletally immature patients; and,
5)cases where there is a loss of abductor musculature,
poor bone stock, or poor skin coverage around the hip joint
which would make the procedure unjustifiable.
1
Preoperative Planning and X-Ray Evaluation
Preoperative planning aids in the selection of the most favorable
implant style and size for the patient’s hip pathology. Optimal
femoral stem fit, prosthetic neck length, angle and version can
be more closely evaluated with the use of preoperative x-ray
analysis. The following parameters should be determined using
an A/P radiograph:
Stem Size
Femoral Offset
Leg Length
Neck Angle
Center of Rotation
1
Trochanteric Fossa
Proximal
Femoral
Axis
Determination of the probable implant size can facilitate operating room preparation and assure availability of an appropriate
size selection. Preoperatively, an x-ray with analysis markings
can be valuable in identifying the appropriate neck resection
level (see below). Anatomic anomalies that could prevent the
intra-operative achievement of the established preoperative
goals may also be detected.
The Pelvic Alignment Level (PAL) is an optional, single use,
sterile hip position reference system that is available for use
during THR. The use of the PAL (cat. no. PAL-400) aids the
surgeon to recognize and understand the impact of intraoperative pelvic motion, and is designed to optimize acetabular
alignment, reduce the chance for post-operative dislocation
and restore femoral leg length and offset.
2
Scale on
Resection Guide
corresponds to
scale on the
templates
Identifying the Proximal Femoral Shaft Axis
39°
Neutral alignment of a straight stem design requires the identification and preparation of the proximal femoral shaft axis. The
trochanteric fossa, a reliable landmark for identifying the proximal
shaft axis, must be unobstructed during preparation to permit
true axial reaming (Figure 1).
Using the
Resection Guide
to determine
resection point
based on lesser
trochanter
1 Femoral Neck Resection
Lay the Stryker Femoral Resection Guide (Figure 2) on the
femur, using the lesser trochanter and the trochanteric fossa as
landmarks when making the final cut. Care should be taken to
align the axis line of the Neck Resection Guide to the center axis
of the femoral shaft; the scales on the lateral flange or medial
radius of the guide can be used to reference the greater or lesser
trochanter respectively when making the final cut.
2
39° Neck resection angle
Tip
The Resection Guide has a threaded hole in the center that
allows attachment to the modular Head and Neck Impactor
shaft to facilitate use in a small operative field.
2 Preparing The Femoral Canal
3
Retraction of the gluteus medius and removal of a portion of the
medial aspect of the greater trochanter will permit true axial
introduction of the instruments and prostheses. A Box Osteotome
is useful in removing bone from this area. Connect the Box
Osteotome attachment to the Modular Handle. Use a Mallet to
strike the end of the Modular Handle with careful controlled
blows to remove remnants of the superior femoral neck and
open the medullary canal (Figure 3). Reposition the Box
Osteotome if further bone removal is desired. Disconnect the
Box Osteotome attachment from the Modular Handle
immediately after use.
Tip
A clear-out hole has been placed on the back of the Box
Osteotome that allows bone to be removed using a Curette
or other OR instruments in an action that does not require
a force to be directed at the cutting surface.
4
Starter Reamer
The Starter Reamer can be used to enter the femoral canal
through the trochanteric fossa. The Starter Reamer has a point
to facilitate entry and graduated markings along the shaft that
correspond to implant sizes.
Enter the canal with the Starter Reamer attached to either a
T-handle or powered instrument. Place the Starter Reamer on
the exposed trochanteric fossa and proceed down into the shaft
along its axis to the appropriate depth. The Starter Reamer
should be inserted such that the appropriate marking corresponding to the preoperatively selected stem size correlates to
the depth of the medial resection point (Figure 4).
Tip
Depth markings on the Starter Reamer, which correspond
to the Tapered Reamer depth for each stem, should be
aligned with the medial aspect of the resection plane.
Reamer
Depth
12
10-11
8-9
6-7
5
4
Medial
Resection
Point
3
Trochanteric Reaming
Select and use the appropriate Trochanteric Reamer to remove
lateral proximal cortical bone. This will further assist in establishing proper axial alignment.
5
The Trochanteric Reamer is available in standard and large sizes.
The Reamer should be inserted to a depth such that the distal
end of the cutting flutes aligns with the medial resection point
(Figure 5). Each Trochanteric Reamer is designed to prepare for
three stem sizes. See Table 1.
Medial
Resection
Point
Option
For Sizes 4-6, the standard Trochanteric Reamer is optional
and to be used according to surgeon’s discretion.
Table 1: Recommended Trochanteric Reamer Sizes
Stem Size
Tapered Reamer
7-9
Standard Trochanteric Reamer
10 - 12
Large Trochanteric Reamer
6
Size 7
Broach Only Option
Size 8
The fully toothed Broaches may facilitate preparation of the
femoral canal without the use of Tapered Reamers. However, a
narrow/tight diaphyseal shaft (e.g. champagne flute femur) may
result in broach resistance in the distal canal. If resistance is
encountered, tapered reaming is recommended to minimize
potential for distal femoral fractures. If the Broach does not seat
at the desired height, ream upward until the Broach seats at the
desired height. The option to skip any reaming step is at the
discretion of the surgeon. Proceed to the next page for
instructions on broaching.
Tapered Reaming
Implant size is determined through templating and broaching.
Reamers are used to prepare the canal distally where dense cortical
bone exists, thereby aiding in broaching. Ream sequentially
upward to one size under the templated size (Figure 6).
Note that although final implant size will be determined via
broaching, the last Tapered Reamer should be equal to or
smaller than the final implant. See Table 2 for a list of recommended Reamer sizes for each stem.
Table 2: Recommended Tapered Reamer Sizes
Stem Size
Tapered Reamer
5
5-6
6
5-6
7
7-8
8
7-8
9
9 - 10
10
9 - 10
11
11 - 12
12
11 - 12
Note
For size 4, Starter Reamer acts as Tapered Reamer.
Tip
If preoperative templating results in an in-between size,
ream to smaller size.
4
Caution
Reamers are sharp and aggressive.
3 Broaching The Femur
7
Assemble the Broach to the Broach Handle by inserting the
alignment tab on the distal end of the Broach Handle into the
Broach (Figure 7). Closing the locking arm until an audible click
is heard secures the Broach onto the Broach Handle.
Using a Mallet with short, controlled strokes, begin broaching
and sequentially broach up until the desired size is reached.
Throughout broaching, continue to apply lateral pressure to
ensure neutral alignment of the implant.
Quick
Release
Button
Correct fit will be denoted by a change in pitch or tactile resistance. To verify a secure fit, attempt to rotate the Broach relative
to the femur. With proper cortical contact, the Broach should
not twist or move relative to the femur. If there is movement,
a larger size broach may be needed.
Locking Arm
Locking Hook
Tip
Alignment Tab
The Stem Impactor can also be used with the Broach Handle
to serve as a version guide (Figure 8). The fitting end of the
Stem Impactor is inserted into the top hole in the Broach
Handle. The Stem Impactor can be held in place while
holding the Broach Handle. Alternately, the Modular
Handle can be connected to the Stem Impactor/Version Bar
fitting to provide greater torsional control.
Broach
8
The final Broach should seat tightly in the femoral canal. The
Broaches are designed to seat to the same level as the implant,
allowing neck trialing to be performed directly off of the Broach.
However, it may be preferable to trial directly off of the
implanted stem.
The Rejuvenate Broaches and Stems are designed to produce a
press-fit gradient (Figure 9). This approach to press-fit design
allows for easier insertion, while enabling initial stability of the
stem. Once optimal fit is achieved, remove the Broach Handle
and proceed to Step 4.
Optional
Trial reduction can be performed using the Broaches.
However, it is recommended that for the Modular Implants,
trial reduction be performed with the Modular Implant to
maximize procedure accuracy.
9
Caution
Proper insertion depth of the Broach in the canal is achieved
when it seats tightly within the canal based on visual and
auditory clues. The surgeon’s clues to firm implant fixation
include increased pitch of sound with blows to Broach
Handle and increased resistance to advancement. Reliance
only on the neck cut may lead to improper sizing, inadequate component fixation, and femoral fracture.
0.125mm press-fit
per side
Press-fit gradient to
end of Plasma Spray
region
Line to line
Note
Regular lubrication of Broach Handle is recommended.
5
4 Calcar Planing
10
Calcar planing creates a final resection plane and angle to optimize
stem fit. There are two Calcar Planers in the set (standard, large).
Select the size that fits the cut surface of the neck. Each Calcar
Planer includes a spring-loaded alignment tab that provides
controlled alignment and engagement with the Broach (Figure 10).
Align the tab within the Broach body, initiate power and press
down to plane the calcar to desired level.
Calcar Planer
Alignment Tab
Note
Calcar Planer removes less than 4mm of bone. Bone remnants
can be removed from the Calcar Planer to continue calcar
planing.
11
Note
Neck Trial
Regular lubrication of Calcar Planers is recommended.
Neck Angle
132°
Caution
Neck Angle
127°
Failure to operate the Calcar Planer in accordance with the
instructions above may result in damage to the femur.
Neck Angle
Direction
Monolithic Stem Option
On the inferior and superior surfaces:
The neck angle marking facing superiorly represents the
angle in use
Neck length
Snap the V40 Head Trial onto the Neck Trial. Perform trial
reduction. After identifying the appropriate head and neck,
remove the Head and Neck Trials from the Broach.
Color
Coding
Version
Degrees
Face of Neck Trial
Note
If neck angle direction arrow points superiorly #, neck angle
is 132° as shown on superior neck angle marking. If neck
angle direction arrow points inferiorly $, neck angle is 127°
as shown on superior neck angle marking.
Table 3: Monolithic Stem Neck and Head Trial Choices
Monolithic Stem
Monolithic Stem Guidelines
For body size 4, do not use femoral head offset greater than
+8mm.
For body size 5, do not use femoral head offset greater than
+12mm.
For body size 6, do not use femoral head offset greater than
+12mm.
Table 3 lists the permissible stem/neck and head combinations for the Monolithic Stems.
Use contrary to these specifications will negate the responsibility of the device manufacturer.
Broach Removal
Attach the Broach Handle to the Broach and extract using a
Mallet. Proceed with stem insertion and final trial reduction
(See Step 6).
6
0°
°
127
There are three monolithic Rejuvenate Stem sizes offered.
Trialing is performed off the Broach with the appropriate Neck
and Head Trials.
Select the appropriate 0° Neck Trial, based on the pre-operative
plan and templating (refer to Table 3). The 0° Neck Trial is
labeled with the following information:
On the end of the trunnion:
0° version degree
Arrow indicating neck angle direction
Black color coding dot
132°
Neck Angle
5 Trial Reduction Off Broach
Stem Size Neck Angle
Neck
Length
Maximum
Femoral
Head
Offset
Max Head
and Neck
Combined
Length
4
132°
26mm
+8mm
34mm
5
132°
26mm
+12mm
38mm
6
132°
26mm
+12mm
38mm
6
127°
30mm
+12mm
42mm
Note
Size 6 is the only monolithic stem available with 127° neck
angle.
Modular Stem Option
Select a Neck Trial, based on the pre-operative plan and
templating (refer to Decision Algorithm in Appendix G). The
Neck Trial is labeled with the following information:
12
Neck Trial
Neck Angle
132°
On the end of the trunnion:
Version degrees
Arrow indicating version and neck angle direction
Color coding dot indicating version
Neck Angle
127°
On the inferior and superior surfaces:
The neck angle marking facing superiorly represents the angle
in use
Neck length
Modular Stem - Modular Neck &
Modular Head Guidelines
Total Head & Neck Construct Length = Head Offset +
Modular Neck Length.
Table 4 below lists the permissible stem/neck and head
combinations. Appendix E lists permissible femoral head
offsets.
Deviation from these specifications may affect the structural
integrity of the neck-stem modular junction.
Use contrary to these specifications will negate the
responsibility of the device manufacturer.
132°
Neck Angle
Direction
Version
Direction
Color
Coding
Version
Degrees
8°
°
127
Once the neck length requirements are established, select a Neck
Trial with the necessary version and varus/valgus orientation that
best reproduces patient biomechanics based on the pre-operative
plan (refer to Neck Trial Option Chart on page 11). Insert the
Neck Trial into the Broach (Figure 12). The Neck Trial will snap
into place. Snap the V40 Head Trial onto the Neck Trial. Perform
trial reduction. After identifying the appropriate Head and Neck,
remove the Head and Neck Trials from the Broach.
Neck Angle
Face of Neck Trial
Note
If neck angle direction arrow points superiorly #, neck angle is
132° as shown on superior neck angle marking. If neck angle
direction arrow points inferiorly $, neck angle is 127° as
shown on superior neck angle marking.
Total Head &
Neck Construct
Length
Table 4:
Max Total Head and Neck Construct Length per Version
Stem Size
Version
7
8
9
10
11
0°
46*
46*
46*
46*
46*
8°
46*
46*
46*
46*
46*
16°
38
38
42
46*
46*
* Achieved only by combining a Modular Neck with a head offset
greater than +0mm.
12
46*
46*
46*
Neck
Length
Head
Offset
Refer to Appendix E for Acceptable Head/Neck combinations and
Appendix H for Component Compatibility.
Tip
Keep the last Neck Trial that was used captured in the Neck
Trial Forceps. This will allow a secondary method of
confirming the desired neck implant.
Total Head
Modular
& Neck
Head
Construct = Offset + Neck
Length
Length
Broach Removal
Attach the Broach Handle to the Broach and extract using a Mallet.
Proceed with stem insertion and final trial reduction (See Step 6).
7
6 Stem Implantation
13a
Option 1:
Stem Inserter
The Rejuvenate Femoral Platform offers two instrument options
to insert the monolithic and modular stems (Figure 13):
Option 2:
Stem Impactor
Note
Prior to proceeding with stem implantation, the surgeon
should follow the standard procedure for femoral canal preparation, including proper irrigation.
Locking
Arm
Modular
Handle
Option 1: The Rejuvenate Stems all have an insertion feature that
consists of a non-threaded hole with a version-control keyway on
the top surface of the proximal body. The Stem Inserter uses a
metal collet that expands inside the insertion feature to form a
secure connection with the stem facilitating stem insertion and
version control. To attach a stem, open the Stem Inserter's
locking arm completely, place tip of Inserter completely into the
insertion feature and ensure proper seating of the key in the
keyway. While holding the stem in position, close the locking
arm of the Inserter to the “closed” position as shown in (Figure
13a).
30°
Max
Stem
Impactor
Do not exceed a
greater than 30°
impacting angle
from the axis of
the stem
Proceed with stem insertion while firmly griping the locking arm.
Use a Mallet with short, controlled strokes to seat the implant.
Typically, the final implant is seated when the proximal edge of
the plasma spray is even with the resection level (Figure 13b).
Note
Do not impact Stem Inserter if it is not completely seated in
the insertion feature. The Inserter is completely seated in the
stem insertion feature when the face of the Inserter is flush
with the top surface of the stem body and the Inserter’s
version key is placed fully in the stem’s keyway.
13b
Resection
Level
Option 2: For surgeons who prefer off-axis stem impaction, the
Rejuvenate Femoral Platform also includes a modular Stem
Impactor. The Stem Impactor has unique distal geometry
designed to allow impaction against the insertion feature. To
prepare the Impactor for use, attach to the Modular Handle.
Proceed with stem insertion. Use a Mallet with short, controlled
strokes to seat the implant. Typically, the final implant is seated
when the proximal edge of the plasma spray is even with the
resection level (Figure 13b).
Note
Use of off-axis Stem Impactor could potentially alter geometry of insertion feature, thus not allowing subsequent use
of Stem Inserter on Modular Stem.
Caution
Caution
The Stem Impactor does not capture the stem. Care should
be taken to prevent it from slipping off the stem and
damaging the trochanter. For best results, use short
controlled mallet strokes. Do not exceed an angle of 30°
from the axis of the stem.
8
The surgeon should NOT attempt to
continue impacting the femoral
component if visual and auditory
clues indicate that the resting position
of the femoral component has been
reached. This can be true even if the
femoral component is not yet down to
the level of the Broach. Continued
aggressive impaction may lead to
femoral fracture.
7 Trial Reduction Off Stem
14
Neck Trial
Adapter
Modular Stem Option Only
The Rejuvenate stem is prepackaged with a Neck Trial Adapter.
This Adapter provides an interface between the Stem and the
Neck Trial. This Adapter remains in the Stem throughout trial
reduction.
Select a Neck Trial, based on the pre-operative plan and
templating (refer to Decision Algorithm in Appendix G).
The Neck Trial is labeled with the following information:
On the end of the trunnion:
Version degrees
Arrow indicating version and neck angle direction
Color coding dot indicating version
Neck Trial
Modular Stem
On the inferior and superior surfaces:
The neck angle marking facing superiorly represents the
angle in use
Neck length
132°
Neck Angle
Neck Angle
Direction
Neck Angle
132°
Neck Angle
127°
Version
Direction
Color
Coding
Version
Degrees
8°
°
127
Once the neck length requirements are established, select a Neck
Trial with the necessary version and varus/valgus orientation that
best reproduces patient biomechanics based on the pre-operative
plan (refer to Neck Trial Option Chart on page 11). Insert the
Neck Trial into the Adapter (Figure 14). The Neck Trial will snap
into place. Snap the V40 Head Trial onto the Neck Trial. Perform
trial reduction. After identifying the appropriate Head and Neck,
remove the Head and Neck Trials from the Adapter.
Modular Stem - Modular Neck &
Modular Head Guidelines
Face of Neck Trial
Total Head & Neck Construct Length = Head Offset +
Modular Neck Length.
Table 4 below lists the permissible stem/neck and head
combinations. Appendix E lists permissible femoral head
offsets.
Deviation from these specifications may affect the structural
integrity of the neck-stem modular junction.
Use contrary to these specifications will negate the
responsibility of the device manufacturer.
Note
If neck angle direction arrow points superiorly #, neck angle is
132° as shown on superior neck angle marking. If neck angle
direction arrow points inferiorly $, neck angle is 127° as
shown on superior neck angle marking.
Total Head &
Neck Construct
Length
Table 4:
Max Total Head and Neck Construct Length per Version
Stem Size
Version
7
8
9
10
11
0°
46*
46*
46*
46*
46*
8°
46*
46*
46*
46*
46*
16°
38
38
42
46*
46*
* Achieved only by combining a Modular Neck with a head offset
greater than +0mm.
12
46*
46*
46*
Refer to Appendix E for Acceptable Head/Neck combinations and
Appendix H for Component Compatibility.
Tip
Neck
Length
Head
Offset
Total Head
Modular
& Neck
Head
Construct = Offset + Neck
Length
Length
Keep the last Neck Trial that was used captured in the Neck
Trial Forceps. This will allow a secondary method of
confirming the desired neck implant.
9
Neck Trial & Implant Labeling Convention
The modular Neck Trials are stored in a color-coded caddy,
organized by length, within the instrument set tray. Each Trial
has a color dot on the end of the trunnion to correspond to the
color and description on the Neck Trial Caddy (Figure 15).
15
Neck Trial Caddy
Once trial reduction is complete, the surgeon can request the
appropriate Modular Neck using neck length and color code.
This will provide sufficient information with which to identify
the correct implant.
On the package label is the Modular Neck catalog number. That
number includes the implant length, the amount of version and
the color code letter. Once the package is opened and the
Modular Neck is removed, the implant is labeled on the trunnion with taper type, implant length and amount of version as
well as arrows indicating version direction and neck angle.
Green
Dot
Neck Trial
Neck
Implant
The example at right demonstrates the labeling convention for a
38mm Modular Neck with 132° neck angle and 8° of anteversion
for use in a right hip. This implant has the green color code
(refer to Neck Trial Option Chart on page 11).
Neck Trial Adapter Removal
Insert the Adapter Removal tool into the Neck Trial Adapter and
squeeze the handle (Figure 16). Remove the Adapter from the
Stem and discard immediately.
Face of Neck Implant
Neck Angle
Direction
Ensure that neither soft tissue nor any other material has entered
the stem taper after removal of the Adapter, and prior to implantation of the Modular Neck. The Stem is now ready to receive a
Neck Implant.
Version
Direction
8° Version
Trunnion
Taper
V40
38mm
8°G
Neck Length
“G”-Green
Note
The Adapter is radiopaque for visualization under X-ray.
The Adapter is intended only for single-use. DO NOT
attempt to reuse. If needed, adapters are available as single,
sterile packaged pieces (cat. no. 1601-2000).
Catalog No. NLV-380800G
Neck Angle
132°
Caution
Neck Angle
127°
Do not apply torsional force to Adaptor during removal.
16
Neck Trial Adapter
Removal Tool
10
Illustration of Neck Trial and
Neck Implant for Right / Left Hip
Right Hip
Right Hip
132° Neck Angle
8° Anteversion
Trial
Left Hip
Left Hip
127° Neck Angle
8° Anteversion
Implant
Anteverted
Implant
Trial
Anteverted
8°
30mm
8°G
V40
V40
30mm
8°G
8°
Face of Neck
Implant
Face of Neck
Trial
Right Hip
127° Neck Angle
8° Retroversion
Trial
Implant
Face of Neck
Trial
Face of Neck
Implant
Left Hip
132° Neck Angle
8° Retroversion
Trial
Implant
Retroverted
Retroverted
8°
30mm
8°G
V40
V40
30mm
8°G
8°
Face of Neck
Trial
Face of Neck
Implant
Face of Neck
Implant
Face of Neck
Trial
Note
Four boxes above demonstrate how the Neck Trial and the Neck Implant can be used in the right and left hip.
Neck Trial Caddy
Neck Trial Option Chart
16°
Retro
Purple
127°
8° Retro
Green
132°
8° Retro
Yellow
127°
0° Neutral
Black
132°
0° Neutral
Black
127°
8° Ante
Yellow
Right Hip
16°
Retro
Purple
132°
8° Ante
Green
16°
Ante
Purple
127°
8° Retro
Yellow
132°
8° Retro
Green
127°
0° Neutral
Black
132°
0° Neutral
Black
127°
8° Ante
Green
Left Hip
132°
8° Ante
Yellow
16°
Ante
Purple
11
8 Neck and Head Implantation
Attach the Modular Handle to the Neck and Head Impactor
(Figure 17). The inside of the tip of the Neck and Head
Impactor is specially shaped to accept the trunnion of the Neck.
Place the Modular Neck into the Modular Stem using the arrows
indicating neck angle and version angle as a guide. Impact the
Modular Neck into the Modular Stem. Two moderate Mallet
blows are sufficient. Impact the Head onto the Modular Neck.
17
Modular
Handle
Neck and
Head Impactor
If utilizing a Cobalt Chrome Head, select the appropriate size
and place it onto the dry trunnion of the Femoral Stem with a
slight twist. Impact the Head with two moderate blows using the
Neck and Head Impactor.
If utilizing a BIOLOX delta ceramic Head, the appropriate size is
intraoperatively assembled to the Neck and is seated with about
two moderate blows using the Neck and Head Impactor. Care
must be taken to avoid excessive impaction forces when assembling the ceramic Head to the Neck. Verify the Head is secure on
the trunnion after impaction. If necessary, the Head can be
removed utilizing the head disassembly instrument.*
Note
Neck and Head Impactor does not hold the Neck or Head.
Reduce the joint and close
Relocate the Femoral Head into the Acetabular Cup and check
the stability and range of motion. The surgical site is then closed
according to the standard procedure for the surgical approach
chosen.
A fully seated neck implant
in the Modular Stem
Postoperative care
Postoperative care should progress according to surgeon preference and recommendation.
* If a BIOLOX delta ceramic Head is placed on the trunnion and
then removed, it must be replaced with a V40 Cobalt Chrome
head, a V40 Titanium Adapter Sleeve (17-0000E) and a C-Taper
ceramic Head or a V40 Universal Adapter Sleeve and a BIOLOX
delta Universal Taper ceramic Head.
Note
If Universal Head is selected, impact Modular Neck to Stem
before placing Universal Adapter Sleeve on Neck.
Note
Alumina ceramic femoral Heads cannot be used directly on
the Cobalt Chrome Modular Neck and require the use of a
Titanium V40 Adapter Sleeve (17-0000E) to convert the V40
stem trunnion to C-Taper.
OPTIONAL STEP
NOTE: When selecting a BIOLOX delta Universal
Taper Ceramic Femoral Head for implantation with
Rejuvenate, use of a V40 Universal Adaptor Sleeve
is necessary (Table 5).
Table 5: Universal Adaptor Sleeves
Universal Adaptor Sleeve
Part Numbers
Taper
Stem Material
Compatibility
19-0XXXT
C-Taper
TMZF, Ti-6Al-4V, CoCr
6519-T-XXX
V40
TMZF, Ti-6Al-4V, CoCr
After completing the trialing process, intraoperatively
assemble the Adaptor Sleeve to the Femoral Stem manually.
The Universal Adaptor Sleeve must be fully seated on the Stem
trunnion before the Head is assembled.
NOTE: In no instance should any attempt be made
to pre-assemble the Adaptor Sleeve inside the
BIOLOX delta Universal Ceramic Head.
Intraoperatively assemble the BIOLOX delta Universal Taper
Ceramic Head onto the sleeved Femoral Stem and set with
one to three moderate blows using the Stem Head Impactor
(1104-1000). Care must be taken to avoid excessive impact
forces when assembling the Ceramic Head to the sleeved
femoral component.
12
APPENDICES
Table of Contents
Appendix A – Options: Modular Neck Extraction................................................................................................................................................ 14
Appendix B – Options: Stem Extraction ................................................................................................................................................................ 14
Appendix C – Modular Instrument Component Diagram ................................................................................................................................. 14
Appendix D – Implant Catalog Numbers and Stem Lengths .................................................................................................................................. 15
Appendix E – Offset Chart and Acceptable Head/Neck Combination Tables...................................................................................................16
Appendix F – Instrument Catalog Numbers ......................................................................................................................................................... 17
Appendix G – Neck Implant Decision Algorithm ................................................................................................................................................. 19
Appendix H – Component Compatibility............................................................................................................................................................... 20
13
Appendix A
Options: Modular Neck Extraction
The Neck Implant is removed with the use of the Rejuvenate Neck
Extractor (Figure 18). The Neck Implant is extracted by placing
the Neck Extractor under either the medial or lateral side of the
base of the Neck and levering out the Neck. Neck Trial Forceps
are recommended to capture the neck during extraction.
Tip
Tap end of Neck Extractor with a Mallet to remove Neck in a
controlled manner.
18
Appendix B
Options: Stem Extraction
There are instruments to manage the extraction of a Monolithic
or Modular Stem in both intraoperative and revision situations
(Figure 19).
The Modular Stem Extractor uses a connection pin, which engages
the stem insertion feature and a locking arm that engages the
Modular Stem taper. The arm is secured in place using a threaded
locking knob. The proximal end of the instrument attaches to a
McReynolds Extractor Assembly (6869-1-000, 6869-2-000, 68693-000) to provide the surgeon with a tool to facilitate the removal
of a well-fixed Femoral Stem. The Modular Stem Extractor
should be reseated and retightened after four extraction blows.
The Monolithic Stem can be extracted with the McReynolds
Distal Stem Adapter (6260-4-090) and McReynolds Driver
(6869-1-000, 6869-2-000, 6869-3-000) from the Restoration
Modular Instrument System.
Caution
Neck Trial
Forceps
Neck
Extractor
Do NOT impact the Locking Knob of the Modular Stem
Extractor as this could damage it.
Note
The Stem Inserter should not be used to extract the Stem.
Neck Implant
19
Monolithic
Stem
Extraction
Modular
Stem
Extraction
Appendix C
Modular Instrument
Component Diagram
McReynolds
Extractor Assembly
20
Box Osteotome
Stem Impactor
Modular Handle
Locking
Knob
McReynolds
Distal Stem
Adapter
Head/Neck
Impactor
Extractor
Locking
Arm
Tip
Ensure instrument is fully seated in the Modular Handle
before use.
14
Extractor
Connection
Appendix D
Implant Catalog Numbers and
Stem Lengths
Table 6: Monolithic Stem, Modular Stem and Modular Neck Implants
Monolithic Stems
Cat. No.
Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 4, 132°
SPT-043100S
Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 5, 132°
SPT-053200S
Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 6, 132°
SPT-063400S
Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 6, 127°
SPT-063800S
Modular Stems
Cat. No.
Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 7
SPT-070000S
Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 8
SPT-080000S
Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 9
SPT-090000S
Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 10
SPT-100000S
Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 11
SPT-110000S
Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 12
SPT-120000S
Modular Necks
Cat. No.
Rejuvenate Modular Neck, 30mm, 0°, 127°/132°, Black
NLS-300000B
Rejuvenate Modular Neck, 30mm, 8° AV/RV, 127°/132°, Yellow
NLV-300800Y
Rejuvenate Modular Neck, 30mm, 8° RV/AV, 127°/132°, Green
NLV-300800G
Rejuvenate Modular Neck, 30mm, 16° RV/AV, 130°, Purple
NLS-301600P
Rejuvenate Modular Neck, 34mm, 0°, 127°/132°, Black
NLS-340000B
Rejuvenate Modular Neck, 34mm, 8° AV/RV, 127°/132°, Yellow
NLV-340800Y
Rejuvenate Modular Neck, 34mm, 8° RV/AV, 127°/132°, Green
NLV-340800G
Rejuvenate Modular Neck, 34mm, 16° RV/AV, 130°, Purple
NLS-341600P
Rejuvenate Modular Neck, 38mm, 0°, 127°/132°, Black
NLS-380000B
Rejuvenate Modular Neck, 38mm, 8° AV/RV, 127°/132°, Yellow
NLV-380800Y
Rejuvenate Modular Neck, 38mm, 8° RV/AV, 127°/132°, Green
NLV-380800G
Rejuvenate Modular Neck, 38mm, 16° RV/AV, 130°, Purple
NLS-381600P
Rejuvenate Modular Neck, 42mm, 0°, 127°/132°, Black
NLS-420000B
Rejuvenate Modular Neck, 42mm, 8° AV/RV, 127°/132°, Yellow
NLV-420800Y
Rejuvenate Modular Neck, 42mm, 8° RV/AV, 127°/132°, Green
NLV-420800G
Rejuvenate Modular Neck, 42mm, 16° RV/AV, 130°, Purple
NLS-421600P
Table 7: Stem Lengths
Stem
Length
Stem Size
4
5
6
7
8
9
10
11
12
Stem Length (mm)
110
115
120
130
136
142
148
155
160
15
Offset
Appendix E
Offset Chart and Acceptable
Head/Neck Combination Tables
Table 8: Monolithic (Offset with +0mm head)
Neck
Stem
Size
4
5
6
127°
NA
NA
38mm
132°
31mm
32mm
34mm
Top View
Tables 9-12: Modular (Offset with +0mm head)
Stem
Size
0° Version
127°
132°
7
8
9
10
11
12
37.7mm
38.6mm
39.8mm
41.0mm
42.0mm
43.1mm
30mm Neck Length
8° Version
16° Version
132°
127°
130°
39.4mm
40.3mm
41.6mm
42.7mm
43.8mm
44.9mm
37.4mm
38.4mm
39.6mm
40.8mm
41.8mm
42.9mm
39.2mm
40.1mm
41.4mm
42.5mm
43.6mm
44.7mm
Stem
Size
7
8
9
10
11
12
37.6mm
38.6mm
39.8mm
41.0mm
42.0mm
43.1mm
38mm Neck Length
0° Version
8° Version
16° Version
132°
127°
127°
130°
132°
Stem
Size
7
8
9
10
11
12
43.6mm
44.5mm
45.7mm
46.9mm
48.0mm
49.0mm
45.8mm
46.7mm
48.0mm
49.1mm
50.2mm
51.3mm
43.3mm
44.2mm
45.5mm
46.6mm
47.7mm
48.8mm
45.5mm
46.5mm
47.7mm
48.8mm
49.9mm
51.0mm
7
8
9
10
11
12
43.6mm
44.5mm
45.7mm
46.9mm
48.0mm
49.0mm
46mm Total Head and Neck Length
0° Version
8° Version
16° Version
132°
127°
127°
130°
132°
49.5mm
50.5mm
51.7mm
52.9mm
53.9mm
55.0mm
52.2mm
53.2mm
54.4mm
55.6mm
55.6mm
57.7mm
49.2mm
50.1mm
51.4mm
52.5mm
53.6mm
54.7mm
51.9mm
52.8mm
54.0mm
55.2mm
56.2mm
57.3mm
40.4mm
41.3mm
42.5mm
43.7mm
44.7mm
45.8mm
42.3mm
43.3mm
44.5mm
45.7mm
46.7mm
47.8mm
40.6mm
41.6mm
42.8mm
43.9mm
45.0mm
46.1mm
42mm Neck Length
0° Version
8° Version
16° Version
132°
127°
127°
130°
132°
46.6mm
47.5mm
48.7mm
49.9mm
50.9mm
52.0mm
49.0mm
50.0mm
51.2mm
52.3mm
53.4mm
54.5mm
46.3mm
47.2mm
48.4mm
49.6mm
50.6mm
51.7mm
48.7mm
49.6mm
50.9mm
52.0mm
53.1mm
54.2mm
N/A
N/A
48.7mm
49.9mm
50.9mm
52.0mm
Table 4: Max Total Head and Neck
Construct Length per Version
(Achieved only by
combining a Modular Neck with a head offset greater than +0mm)
7
8
9
10
11
12
34mm Neck Length
8° Version
16° Version
132°
127°
130°
42.6mm
43.5mm
44.8mm
45.9mm
47.0mm
48.1mm
40.6mm
41.6mm
42.8mm
44.0mm
45.0mm
46.1mm
Stem
Size
Table 13: Max Achievable Offset
Stem
Size
0° Version
127°
132°
Stem Size
Version
7
8
9
10
11
0°
46*
46*
46*
46*
46*
8°
46*
46*
46*
46*
46*
16°
38
38
42
46*
46*
* Achieved only by combining a Modular Neck with a head offset
greater than +0mm.
N/A
N/A
N/A
52.9mm
53.9mm
55.0mm
12
46*
46*
46*
Table 14: Head and Neck Combination*
Modular Neck
Implant
-5mm
†
-4mm
Femoral Head Offsets*
-2.7mm -2.5mm +0mm +2.5mm +3mm +4mm
+5mm +7.5mm +8mm +10mm +12mm
30mm
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔
✔†
✔†
34mm
✔
✔
✔
✔
✔
✔
✔
✔
✔†
✔†
✔†
✔ †‡
✔ †‡
38mm
✔
✔
✔
✔
✔
✔†
✔†
✔†
✔ †‡
✔ †‡
✔ †‡
42mm
✔
✔
✔†
✔†
✔†
✔ †‡
✔ †‡
✔ †‡
16° version not compatible with sizes 7 & 8
‡
16° version not compatible with size 9
* Not all offsets are available in all materials or all diameters. The table includes C-taper and V40 offset head options. Use of the
C-taper head requires the assembly of a Titanium Adapter Sleeve (17-0000E) to convert the V40 stem trunnion to C-taper.
See Appendix H for information on Component Compatibility for modular heads and acetabular components.
Note
Tables above may not be an exhaustive list of all femoral head options in
all materials.
16
Appendix F
Instrument Catalog Numbers
Table 15: Rejuvenate Primary Instruments
Rejuvenate Primary Instruments (continued)
Cat. No.
Description
Cat. No.
Description
1601-1600
Rejuvenate Stem Inserter
1601-2730
1601-1650*
Rejuvenate Modular Stem Extractor
Rejuvenate 30 mm, 8 Degree Neck Trial
RV/AV 127/132 Degree Green
1601-1690
Rejuvenate Stem Impactor
1601-2734
1601-1700
Rejuvenate Head/Neck Impactor
Rejuvenate 34 mm, 8 Degree Neck Trial
RV/AV 127/132 Degree Green
1601-1801
Rejuvenate Neck Extractor
1601-2738
Rejuvenate 38 mm, 8 Degree Neck Trial
RV/AV 127/132 Degree Green
1601-1100*
Rejuvenate Broach Handle
1601-2742
1601-1900
Rejuvenate Adaptor Removal Tool
Rejuvenate 42 mm, 8 Degree Neck Trial
RV/AV 127/132 Degree Green
1440-1700
Offset Neck Trial Forceps
1601-2830
1101-2200
Orthonomic T-Handle
Rejuvenate 30 mm, 16 Degree Neck Trial 130
Degree Purple
1020-2900
Orthonomic Modular Handle
1601-2834
1601-2526
Rejuvenate 26 mm, 0 Degree Neck Trial
127/132 Degree Black
Rejuvenate 34 mm, 16 Degree Neck Trial 130
Degree Purple
1601-2838
1601-2530
Rejuvenate 30 mm, 0 Degree Neck Trial
127/132 Degree Black
Rejuvenate 38 mm, 16 Degree Neck Trial 130
Degree Purple
1601-2842
1601-2534
Rejuvenate 34 mm, 0 Degree Neck Trial
127/132 Degree Black
Rejuvenate 42 mm, 16 Degree Neck Trial 130
Degree Purple
1601-5010
Rejuvenate Neck Trial Caddy 26mm & 30mm
1601-2538
Rejuvenate 38 mm, 0 Degree Neck Trial
127/132 Degree Black
1601-5011
Rejuvenate Neck Trial Caddy 34mm
1601-5012
Rejuvenate Neck Trial Caddy 38mm
1601-2542
Rejuvenate 42 mm, 0 Degree Neck Trial
127/132 Degree Black
1601-5014
Rejuvenate Neck Trial Caddy 42mm
1601-2630
Rejuvenate 30 mm, 8 Degree Neck Trial
AV/RV 127/132 Degree Yellow
1601-2634
Rejuvenate 34 mm, 8 Degree Neck Trial
AV/RV 127/132 Degree Yellow
Table 16: Trial Heads
Cat. No.
Description
6264-8-132R
32mm STD V40 Trial Head
36mm STD V40 Trial Head
1601-2638
Rejuvenate 38 mm, 8 Degree Neck Trial
AV/RV 127/132 Degree Yellow
6264-8-136R
1601-2642
Rejuvenate 42 mm, 8 Degree Neck Trial
AV/RV 127/132 Degree Yellow
Note
A total of 9 trial heads can be placed in the instrument tray.
* Regular lubrication recommended. Refer to lubrication procedure,
Literature LRJ-ISS.
17
Appendix F
Instrument Catalog Numbers
(continued)
Table 17: Rejuvenate Femoral Preparation
Instrumentation
Table 18: Rejuvenate Instrument Cases
Cat. No.
Description
Cat. No.
Description
1601-1004A
Rejuvenate Broach, Straight, size 4
1601-5000
Rejuvenate Instrument Case
1601-1005A
Rejuvenate Broach, Straight, size 5
1601-5001
Rejuvenate Femoral Tray 1
1601-1006A
Rejuvenate Broach, Straight, size 6
1601-5002
Rejuvenate Femoral Tray 2
1601-1007A
Rejuvenate Broach, Straight, size 7
1601-5003
Rejuvenate Procedure Tray 1
1601-1008A
Rejuvenate Broach, Straight, size 8
1601-5004
Rejuvenate Procedure Tray 2
1601-1009A
Rejuvenate Broach, Straight, size 9
1601-1010A
Rejuvenate Broach, Straight, size 10
1601-1011A
Rejuvenate Broach, Straight, size 11
Cat. No.
Description
1601-1012A
Rejuvenate Broach, Straight, size 12
6260-4-090
McReynolds Distal Stem Adapter
1601-1210
Modular Box Osteotome
6869-1-000
Shaft, McReynolds Extractor Assembly
1601-1300
Rejuvenate Neck Resection Guide
6869-2-000
1601-1310
Ruler
Driving Handle, McReynolds Extractor
Assembly
1601-1400*
Rejuvenate Calcar Planar, Standard
6869-3-000
1601-1420*
Rejuvenate Calcar Planar, Large
Sliding Hammer, McReynolds Extractor
Assembly
1601-1504
Rejuvenate Starter Reamer
1601-1531
Rejuvenate Trochanteric Reamer, Standard
1601-1532
Rejuvenate Trochanteric Reamer, Large
Cat. No.
Description
1601-1556
Rejuvenate 2-for-1 Tapered Reamer, Size 5-6
1601-2000
Neck Trial Adapter (1 piece sterile)
1601-1578
Rejuvenate 2-for-1 Tapered reamer, Size 7-8
1601-1590
Rejuvenate 2-for-1 Tapered Reamer, Size 9-10
1601-1512
Rejuvenate 2-for-1 Tapered Reamer, Size 11-12
* Regular lubrication recommended. Refer to lubrication procedure,
Literature LRJ-ISS.
18
Table 19: Ancillary Extraction Instruments
Table 20: Miscellaneous
Appendix G
Neck Implant Decision Algorithm
Sizes 7, 8, 9
Sizes 10, 11, 12
Choose Stem Angle
Based on Patient Anatomy
127° or 132°
Choose Stem Angle
Based on Patient Anatomy
127° or 132°
Choose Neutral (Black) Neck
34mm *
Choose Neutral (Black) Neck
38mm *
Std. +0mm trial head (Black)
Std. +0mm trial head (Black)
Trial Reduction Step #1 –
Leg Length and Offset Assessment
Trial Reduction Step #1 –
Leg Length and Offset Assessment
Increase or Decrease
Neck Length
Increase or Decrease
Neck Length
Increase or Decrease Head Offset – Fine Tuning
Options depend on head diameter and material
Increase or Decrease Head Offset – Fine Tuning
Options depend on head diameter and material
Trial Reduction Step #2 –
Version Assessment
Trial Reduction Step #2 –
Version Assessment
Flexion Impingement
Use 8
Anteverted neck†
†
Extension
Impingement
Use 8
Retroverted neck†
16 version can also be used, but
neck angle will change to 130°
Flexion Impingement
Use 8
Anteverted neck†
†
Extension
Impingement
Use 8
Retroverted neck†
16 version can also be used, but
neck angle will change to 130°
* Suggested starting point – final selection should be based on surgeon’s discretion. Total head and neck construct length should follow guidelines
indicated in Appendix E.
19
Appendix H Component Compatibility
Modular Heads
Additional Information for Constrained Liners
Table 21 includes a list of compatible Femoral Heads. See the
package insert accompanying the specific component for the
indications, contraindications, warnings, precautions and other
information regarding the use of the Head. Maximum offset
used may be restricted by Modular Stem body size and Modular
Neck combinations. See Step 7 for Modular Stem-Modular Neck
& Modular Head Guidelines for the appropriate combinations.
Constrained Liners are intended for use in primary or revision
patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease
or intraoperative instability.
Table 21
Compatible Femoral Heads
Offset
V40 BIOLOX delta
-5mm to +7.5mm
V40 LFIT CoCr
-5mm to +12mm
C-Taper Alumina*
-5mm to +5mm
V40/C-taper Adapter Sleeve
*Requires use of a Titanium V40 Adapter Sleeve (17-0000E) to
convert the V40 stem trunnion to C-Taper.
Compatible Acetabular Components
The compatible Heads may be used with compatible Stryker
unipolar, bipolar and acetabular components. Table 22 includes
a list of compatible acetabular components. See the package
insert accompanying the specific component for the indications,
contraindications, warnings, precautions and other information
regarding the use of the Head. See the individual surgical techniques for implantation of the acetabular components.
Table 22
Compatible Acetabular Components
Trident X3 Acetabular Inserts
Trident Crossfire Elevated Rim Liners
Trident Crossfire Polyethylene Liners, 10º or 0º profile
Trident Crossfire Eccentric Poly Liners, 10º or 0º profile
Trident Poly Liners, 10º or 0º profile
Trident Eccentric Poly Liners
Trident Constrained Insert
Trident All Poly Cup
Trident Crossfire All Poly Cup
Unitrax Unipolar Head
UHR Bipolar Head
Trident N2/Vac Polyethylene Inserts
Trident Hemispherical Shells
Trident Hemispherical HA Shells
Trident PSL HA Shells
Trident Tritanium Shells
Trident Alumina Insert used with a C-taper Alumina Head
and a V40/C-taper Adapter Sleeve
Restoration ADM Shells
Tritanium PSF Shells
Constrained Liners are contraindicated in patients with the
following conditions: bone or musculature compromised by
disease, infection or prior implantation, which cannot provide
adequate support or fixation for the prosthesis, infection in or
about the hip joint or skeletal immaturity.
See the package insert accompanying the Constrained Liner for
the indications, contraindications, warnings, precautions and
other information regarding the use of the liner. See the surgical
technique of the specific liner for the steps to appropriately
implant the component.
Compatible Ceramic Femoral Heads
Table 23: V40 Taper BIOLOX delta Ceramic Heads
Catalog
Diameter
Offset
Trial
No.
(mm)
(mm)
Catalog No.
6570-0-028
28
-4
6264-8-028R
6570-0-328
28
-2.7
6264-8-928R
6570-0-128
28
+0
6264-8-128R
6570-0-228
28
+4
6264-8-228R
6570-0-032
32
-4
6264-8-032R
6570-0-132
32
+0
6264-8-132R
6570-0-232
32
+4
6264-8-232R
6570-0-036
36
-5
6264-8-036R
6570-0-436
36
-2.5
6264-8-436R
6570-0-136
36
+0
6264-8-136R
6570-0-536
36
+2.5
6264-8-536R
6570-0-236
36
+5
6264-8-236R
6570-0-736
36
+7.5
6264-8-736R
Table 24: C-Taper BIOLOX delta Ceramic Heads
Catalog
Diameter
Offset
Trial
No.
(mm)
(mm)
Catalog No.
18-28-3
28
-2.5
1100-2897R
18-2800
28
+0
1100-2800R
18-2825
28
+2.5
1100-2825R
18-2805
28
+5
1100-2805R
18-32-3
32
-2.5
1100-3297R
18-3200
32
+0
1100-3200R
18-3225
32
+2.5
1100-3225R
18-3205
32
+5
1100-3205R
18-36-5
36
-5
1100-3699R
18-36-3
36
-2.5
1100-3697R
18-3600
36
+0
1100-3600R
18-3625
36
+2.5
1100-3625R
18-3605
36
+5
1100-3605R
18-3675
36
+7.5
1100-3675R
Requires use of a Titanium V40 Adapter Sleeve (17-0000E) to convert
the V40 stem trunnion to C-Taper
Note
Tables above may not be an exhaustive list of all options in
all materials.
Compatible Femoral Heads continued on next page.
20
Compatible Ceramic Femoral Heads (continued)
Table 25: Universal Taper BIOLOX delta Ceramic Heads
Catalog No.
Diameter (mm)
6519-1-028
6519-1-032
6519-1-036
6519-1-040
6519-1-044
Requires use of Universal Adapter Sleeve.
28
32
36
40
44
Table 26: Universal Trial Heads
Catalog
Diameter
Offset
No.
(mm)
(mm)
6264-8-728R
6264-8-632R
6264-3-236R
6264-8-940R
6264-8-944R
28
32
36
40
44
-2.5
-2.5
+4.0
-2.5
-2.5
Taper
V40
V40
V40
V40
V40
Table 28: C-Taper Alumina Ceramic Heads
Catalog
Diameter
Offset
Trial
(mm)
(mm)
Catalog No.
No.
17-28-3E
28
–2.5
1100-2897R
17-2800E
28
+0
1100-2800R
17-2805E
28
+5
1100-2805R
17-32-3E
32
–2.5
1100-3297R
17-3200E
32
+0
1100-3200R
17-3205E
32
+5
1100-3205R
17-36-5E
36
–5
1100-3699R
17-3600E
36
+0
1100-3600R
17-3605E
36
+5
1100-3605R
Requires use of a Titanium V40 Adapter Sleeve (17-0000E) to convert
the V40 stem trunnion to C-Taper
Table 27: Universal Adapter Sleeves - Titanium
Catalog No.
Offset (mm)
Taper
6519-T-025
6519-T-100
6519-T-204
-2.5
+0
+4
V40
V40
V40
Compatible CoCr Femoral Heads
Table 29: V40 Taper LFIT Heads
Catalog
Diameter
Offset
No.
(mm)
(mm)
6260-9-122
22
+0
6260-9-222
22
+3
6260-9-322
22
+8
6260-9-026
26
-3
6260-9-126
26
+0
6260-9-226
26
+4
6260-9-326
26
+8
6260-9-426
26
+12
6260-9-028
28
-4
6260-9-128
28
+0
6260-9-228
28
+4
6260-9-328
28
+8
6260-9-428
28
+12
6260-9-032
32
-4
6260-9-132
32
+0
6260-9-232
32
+4
6260-9-332
32
+8
6260-9-432
32
+12
Trial
Catalog No.
6264-8-122R
6264-8-222R
6264-8-322R
6264-8-026R
6264-8-126R
6264-7-226R
6264-8-326R
6264-8-426R
6264-8-028R
6264-8-128R
6264-8-228R
6264-8-328R
6264-8-428R
6264-8-032R
6264-8-132R
6264-8-232R
6264-8-332R
6264-8-432R
Table 30: V40 Taper LFIT Anatomic Heads
Catalog
Diameter
Offset
Trial
No.
(mm)
(mm)
Catalog No.
6260-9-036
36
-5
6264-8-036R
6260-9-136
36
+0
6264-8-136R
6260-9-236
36
+5
6264-8-236R
6260-9-336
36
+10
6264-8-336R
6260-9-040
40
-4
6264-8-040R
6260-9-140
40
+0
6264-8-140R
6260-9-240
40
+4
6264-8-240R
6260-9-340
40
+8
6264-8-340R
6260-9-440
40
+12
6264-8-440R
6260-9-044
44
-4
6264-8-044R
6260-9-144
44
+0
6264-8-144R
6260-9-244
44
+4
6264-8-244R
Note
Tables above may not be an exhaustive list of all options in
all materials.
21
References
1. Steppacher, S.D., Ecker, T.M., et al. Managing Length and Stability: The role of the modular neck.
Orthopaedics, Vol.31, No.9, September 2008.
2. RD-07-027 Fatigue Performance of the Rejuvenate Modular Stem/neck construct under a modified
ISO neck test model.
3. Capello, W., et al. Hydroxyapatite-coated Femoral Components, 15-Year Minimum Followup,
CORR, Vol.453, December 2006:pp.75 - 80.
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