KL 6628 Uniflex FILM

®
UNIFLEX
Nailing System
NIFLEXIBILITY
Titanium Alloy Construction
Compared to stainless steel, titanium alloy provides added
strength for internal fixation of shaft fractures with a lower
modulus of elasticity. The resultant flexibility aids in the
insertion of the nail and results in increased load transfer
to the bone to stimulate fracture healing.
Convenient, Sterile Packaging
Implants are packaged pre-sterile for convenience
and assured sterility in the operating room.
Simplified Nail Removal
The end cap threads into the proximal end of the nail,
reducing the possibility of fibrous tissue growth into the
threads. Upon removal of the end cap, threads are clear,
facilitating extraction.
Faster Insertion with Pathfinder™ Tips
The tapered design of the Pathfinder Tip aids passage
down the intramedullary canal and across the fracture site,
while reducing the risk of cortical impingement.
Simple, Accurate Instrumentation
Precise reproducible instruments thread easily into the
nails, providing exceptional control and rotational stability
during insertion and extraction. One thread
size for all nails simplifies instrumentation.
Instruments are well organized in a single
sterilization case for convenience.
Surgical Latitude
The Uniflex Family of Intramedullary Nails can be
utilized in a reamed or nonreamed mode, based on
surgeon preference and individual patient requirements.
For Your
Most
Demanding
Cases
Titanium alloy provides a unique
blend of strength and flexibility, ideal
for intramedullary fixation. The yield
strength of titanium alloy is twice that
of stainless steel and its ultimate tensile
strength is almost 25% higher. In
addition, the combined mechanical
properties of high strength and a
lower modulus of elasticity allow the
Uniflex Nail to potentially offer
reduced implant failure and improved
stimulation of fracture healing.
1
roven Küntscher concept of a full
longitudinal slot promotes healing by
allowing micromotion at the fracture
site. The longitudinal slot compresses
during insertion making the nail more
“forgiving” and requiring overreaming
of only 1-1.5mm. ■ The yield strength
of titanium alloy is twice that of stainless steel and its ultimate tensile strength is almost 25% higher. ■ Two proximal
reconstructive screw holes are placed at a 125o neck/shaft angle and anteverted left
and right 9o to accommodate the anteversion of the femoral neck. Distal screw holes
are positioned to capture fragments close to the femoral condyles. ■ Much stronger
than stainless steel, self-tapping titanium screws allow for easy insertion and
increased strength and are available in 9 lengths. ■ Uniflex Nails are left
and right bowed and are available in diameters from 10mm to 16mm and lengths
from 32cm to 48cm.
Case Data
Pre-op X-ray of a male who sustained a combination fracture of the femoral neck and shaft
in a motorcycle accident.
11 months post-op X-ray showing the Uniflex
Nail in reconstructive fixation with fracture healing and no signs of avascular necrosis.
Uniflex Femoral Nail
2
Preoperative
Postoperative
Reamed or Unreamed, the Uniflex Nail addresses a wide range of femoral fractures with one system.
Standard Intramedullary
Indications:
• Noncomminuted midshaft fractures (A)
Interlocking Indications
• Comminuted shaft fractures (B)
• Subtrochanteric fractures (C)
• Distal third fractures (D)
Reconstructive Indications:
• Combination fractures of the shaft and neck (E)
• Intertrochanteric fractures (F)
A
B
C
D
E
F
G
• Combined intertrochanteric and subtrochanteric fractures (G)
• Reconstruction following tumor resection
Simple, Accurate
Instrumentation
Instruments thread easily into the
nails providing exceptional control
and rotational stability during
insertion and extraction. One
thread size for all nails simplifies
instrumentation. Instruments are
well organized in a single sterilization
case for convenience.
The Uniflex® Femoral Nail System
was developed in cooperation
with the Biomechanics Research
Laboratory of Orthopaedic
Hospital/USC and the Department
of Orthopaedics, University of
Southern California School of
Medicine.
3
uch stronger than stainless steel
in yield strength, and 25% higher
in ultimate tensile strength, selftapping titanium screws allow
for easy insertion, increased
strength, and are available in
10 lengths. ■ In addition, the
combined mechanical properties of
high strength and a lower modulus of elasticity allow the Uniflex Nail to offer a
potential reduction of implant failure and improved stimulation of fracture healing.
■ Distal screw holes are positioned to capture fragments close to the femoral
condyles. ■ Uniflex Tibial Nails are available in lengths from 24cm to 38cm in the
8mm and 9mm diameter nails and 24cm to 42cm in the 10mm through 14mm
diameter nails.
Uniflex Tibial Nail
4
Case Data
Age/Sex: 29/Male
Injury: Motor vehicle accident
Fracture: Distal oblique
Fixation: Static locked nail
Date of Surgery: 1-6-91
Preoperative
Postoperative
Simple, Accurate
Instrumentation
Instruments thread easily into the
nails providing exceptional control
and rotational stability during
insertion and extraction. One
thread size for all nails simplifies
instrumentation. Instruments are
well organized in a single sterilization
case for convenience.
The Uniflex® Tibial Nail System
was developed in cooperation
with the Biomechanics Research
Laboratory of Orthopaedic
Hospital/USC and the Department
of Orthopaedics, University of
Southern California School of
Medicine.
5
umeral nails of titanium alloy
provide a unique blend of strength
and flexibility. ■ Ideally suited for
intramedullary fixation, the yield
strength of titanium alloy is twice
that of stainless steel and its ultimate
tensile strength is almost 25%
higher. ■ In addition, the combined
mechanical properties of high strength and a lower modulus of elasticity allow
the Uniflex Nail to offer a potential reduction of implant failure and improved
stimulation of fracture healing. ■ Self-tapping titanium screws allow for easy
insertion and increased strength, and are available in 6 lengths. Uniflex
Humeral Nails are available in diameters of 8mm and 9mm and lengths of
18cm to 28cm.
Case Data
Open segmental humerus fracture
associated with multiple blunt trauma.
Uniflex Humeral Nail
6
Preoperative
Postoperative
Indications
Most fractures of the humerus will
heal in a satisfactory fashion without operation. However, the
Uniflex Humeral Nail System has
been designed to treat certain
difficult humeral fractures in
which noninvasive treatments
have historically failed to give
predictable results.
Nonunion
Malunion
Metastatic
Disease
Mulitple Trauma
w/ Head Injury
Pathological
Fracture
Simple, Accurate
Instrumentation
Although proximally attached distal
alignment guides for locking distal
screws have not generally performed
well in the femur, the humerus is
shorter and lighter and is exposed
to milder intraoperative stresses,
allowing use of the distal target
guide. This greatly simplifies the
need for intraoperative imaging.
Instruments thread easily into the
nails providing exceptional control
and rotational stability during
insertion and extraction. One thread
size for all nails simplifies instrumentation. Instruments are well
organized in a single sterilization
case for convenience.
The Uniflex® Humeral Nail System
was developed in conjunction with
Ralph B. Blasier, M.D., Chief of
Orthopaedics, Grace Hospital,
Detroit, MI.
7
Nailing System
Ordering Information
NOTE: When implanting
a 10mm-13mm
Uniflex Femoral Nail, it
is extremely important
to ream the entry portal
to 14mm in diameter to
a depth of approximately
3" (8 cm) below the
entry portal.
Right Reconstructive
Grooves in titanium screw heads distinguish them from
stainless steel screws.
Uniflex® Titanium Nail Right Interlocking
Left Reconstructive
Part Number
Length
32cm
34cm
36cm
38cm
40cm
42cm
44cm
46cm
48cm
10mm
Diameter
11mm
Diameter
12mm
Diameter
13mm
Diameter
14mm
Diameter
15mm
Diameter
16mm
Diameter
341232
341234
341236
341238
341240
341242
341244
341246
341248
341332
341334
341336
341338
341340
341342
341344
341346
341348
341432
341434
341436
341438
341440
341442
341444
341446
341448
341532
341534
341536
341538
341540
341542
341544
341546
341548
341632
341634
341636
341638
341640
341642
341644
341646
341648
341732
341734
341736
341738
341740
341742
341744
341746
341748
341832
341834
341836
341838
341840
341842
341844
341846
341848
5mm diameter screws
are used only for the distal
holes in the 10mm and
11mm diameter nails.
Primary set
Uniflex® Titanium Nail Left Interlocking
Right Reconstructive
Part Number
Length
32cm
34cm
36cm
38cm
40cm
42cm
44cm
46cm
48cm
10mm
Diameter
11mm
Diameter
12mm
Diameter
13mm
Diameter
14mm
Diameter
15mm
Diameter
16mm
Diameter
342732
342734
342736
342738
342740
342742
342744
342746
342748
342832
342834
342836
342838
342840
342842
342844
342846
342848
342932
342934
342936
342938
342940
342942
342944
342946
342948
343032
343034
343036
343038
343040
343042
343044
343046
343048
343132
343134
343136
343138
343140
343142
343144
343146
343148
343232
343234
343236
343238
343240
343242
343244
343246
343248
343332
343334
343336
343338
343340
343342
343344
343346
343348
5mm diameter screws
are used only for the distal
holes in the 10mm and
11mm diameter nails.
8
Titanium Low Profile End Cap
345211
Left Interlocking
Titanium
Screw
Buttress
Thread
Titanium
Screw
Buttress
Thread
5mm
Diameter*/
Fully
Threaded
6mm
Diameter*/
Fully
Threaded
Note: All
Note: All
proximal
proximal
holes use
holes use
the 5mm
the 5mm
diameter
diameter
screws
screws
Use Twist Use Twist
Drill 4.3mm Drill 4.3mm
Diameter
Diameter
Part
Number
33-345420
33-345422
33-345424
33-345426
33-345428
33-345430
33-345432
33-345434
33-345436
33-345438
33-345440
33-345442
33-345444
33-345446
33-345448
33-345450
33-345452
33-345454
Part
Number
Length
––
25mm
33-345520 30mm
33-345522 35mm
33-345524 40mm
33-345526 45mm
33-345528 50mm
33-345530 55mm
33-345532 60mm
33-345534 65mm
33-345536 70mm
33-345538 75mm
33-345540 80mm
33-345542 85mm
33-345544 90mm
33-345546 95mm
33-345548 100mm
––
105mm
––
110mm
(*5mm diameter screws are used only for distal
holes in the 10mm and11mm diameter nails)
Titanium Fixation Screws
6.3mm Diameter /
Partially Threaded
Reconstructive Only
Part Number
Length
345620
345622
345624
345626
345628
345630
345632
345634
345636
345638
345640
70mm
75mm
80mm
85mm
90mm
95mm
100mm
105mm
110mm
115mm
120mm
nstrumentation
Driver with Handle
471720 (Patent No. 4,911,153)
Driver Bolt
471722
HIGH CLEARANCE ONLY:
High Clearance Driver w/ Handle
471710
Driver Bushing
471723
High Clearance Driver Bolt
471712
Offset Driver
471730
High Clearance Offset Driver
471714
Plain Bar
471731
High Clearance Proximal Target
471716
Universal Hex Socket Wrench
471756 19mm(3⁄4")
INTERLOCKING ONLY:
Titanium End Wrench
471758 19mm(3⁄4")
Guide Tube A
471732
Hex Drive T-Wrench
471760 5mm x 280mm
Trocar for Guide Tube A
471733
Hex Drive Power Bit
471761 5mm
Drill Bushing A
471734 5mm
Nail Extractor w/ Slide Hammer
471764
Calibrated Drill (Sterile)
471736 5mm x 254mm
Nail Extractor Adaptor
471768
RECONSTRUCTIVE ONLY:
Nail Extractor Hook w/ Adaptor
471770
8mm Medullary Alignment Tube - Pkg./6
469388 with ring
469392 without ring
Screw Depth Gauge
34-513646
FOR 10MM AND 11MM NAILS
(DISTAL HOLES ONLY):
Twist Drill (Sterile)
472255 4.3mm x 180mm
Hex Drive T-Wrench
457118 3.5mm
Radiolucent Distal Targeting Device
471860 Device
471872 4.3mm drill bit for 10mm and
11mm nail
471878 5.0mm drill bit
Distal Targeting Awl
471794 4.3mm for 10mm and
11mm nail
471795 5.0mm
For Freehand Distal Targeting
Depth Gauge for Crowe Point
Twist Drill
472080
4.3mm Crowe Point Twist Drill (Sterile)
472068
5.0mm Crowe Point Twist Drill (Sterile)
472074
Guide Pin
27-361681 3.2mm x 305mm
(1⁄8" x 12") Pkg./6
25-361681 3.2mm x 305mm
(1⁄8" x 12") Pkg./5 (Sterile)
Templates
471750
Proximal Target for Standard Driver
471740
SUGGESTED ADDITIONAL
INSTRUMENTATION
Nail Driving Guide (2 ea.)
467220 4.4mm x 80cm
Guide Tube B - (Req. 2 ea.)
471742
Reduction Lever
469385
Trocar Guide Tube B
471743
Instrument Case
592024 Case 1
592025 Case 2
Drill Bushing B - (Req. 2 ea.)
471744 6.2mm
Guide Bushing B - (Req. 2 ea.)
471746 3.2mm
Calibrated Step Drill (Sterile)
471748 6.2mm x 330mm
Video
Y-BVP-067V
Skin Protector
476920
X-ray Scale
475920
9mm T-handle Reamer
468138
Guide Pin Hand Grip
469675
469685 Replacement Collet
9
Nailing System
Ordering Information
Uniflex® Titanium Tibial Nails
Part Number
Length
8mm
Diameter
9mm
Diameter
10mm
Diameter
11mm
Diameter
12mm
Diameter
13mm
Diameter
14mm
Diameter
24cm
33-344024
33-344124
33-344224
33-344324
33-344424
33-344524
33-344624
26cm
28cm
30cm
32cm
34cm
36cm
38cm
40cm
42cm
33-344026
33-344028
33-344030
33-344032
33-344034
33-344036
33-344038
––
––
33-344126
33-344128
33-344130
33-344132
33-344134
33-344136
33-344138
––
––
33-344226
33-344228
33-344230
33-344232
33-344234
33-344236
33-344238
33-344240
33-344242
33-344326
33-344328
33-344330
33-344332
33-344334
33-344336
33-344338
33-344340
33-344342
33-344426
33-344428
33-344430
33-344432
33-344434
33-344436
33-344438
33-344440
33-344442
33-344526
33-344528
33-344530
33-344532
33-344534
33-344536
33-344538
33-344540
33-344542
33-344626
33-344628
33-344630
33-344632
33-344634
33-344636
33-344638
33-344640
33-344642
4mm diameter screws
are used only for the distal
screw holes in the 8mm
and 9mm diameter nails.
5mm diameter screws are used for the distal screw holes in the
10mm through 14mm diameter nails.
Titanium Fixation Screws
Titanium End Cap
345215
10
Primary set
Titanium Screw Buttress Thread
4mm Diameter / Fully Threaded
5mm Diameter / Fully Threaded
(4mm diameter screws are used
only for distal holes in the
8mm and 9mm diameter nails)
Note: All proximal holes use the 5mm
diameter screws
Use Twist Drill 4.3mm Diameter
Part Number
Length
Part Number
Length
345264
345266
345268
345270
345272
345274
345276
345278
345280
345282
345284
345286
345288
345290
345292
345294
345296
20mm
22mm
24mm
26mm
28mm
30mm
32mm
34mm
36mm
38mm
40mm
42mm
44mm
46mm
50mm
54mm
58mm
33-345418
33-345420
33-345422
33-345424
33-345426
33-345428
33-345430
33-345432
33-345434
33-345436
33-345438
33-345440
33-345442
33-345444
33-345446
33-345448
33-345450
33-345452
33-345454
20mm
25mm
30mm
35mm
40mm
45mm
50mm
55mm
60mm
65mm
70mm
75mm
80mm
85mm
90mm
95mm
100mm
105mm
110mm
nstrumentation
Driver Bushing
471615
3.5mm Hex Drive T-Wrench
457118
SUGGESTED ADDITIONAL
INSTRUMENTATION
Driver Bolt
471525
T-Wrench 3⁄8" Hex
449110
Skin Protector
476920
Target Arm
471630
Nail Driving Guide
3.2mm x 80cm (2 ea.)
467210
Reduction Lever
469385
Driver Handle (Threaded)
471535
Depth Gauge
34-513644
Driver Handle (Plain)
471635
Nail Extractor Adaptor
471560
Proximal Target
471640
Slide Hammer
471565
Guide Tube (2 ea.)
471545
Instrument Case
592136
Trocar for Guide Tube
471546
6.3mm Medullary Alignment Tube
(for use w/8-9mm nails) Pkg./6 (Sterile)
469394 with ring
Drill Bushing 4.3mm (2 ea.)
471650
Calibrated Twist Drill
4.3mm x 203mm (Sterile)
471655
Twist Drill 3.6 x 180mm (Sterile)
472366 3.6 x 180mm (Sterile)
472368 3.2 x 180mm (Sterile)
Cortical Step Drill
5
⁄16" (8mm) x 1⁄2" (12.7mm) Dia.
464530
8mm Medullary Alignment Tube
(for use w/10-14mm nails) Pkg./6 (Sterile)
469388 with ring
469392 without ring
Radiolucent Distal
Targeting Device (Sterile)
471860
X-ray Scale
475920
Diamond Point Tibial Awl
470320
Guide Pin Hand Grip
469675
469685 Replacement Collet
Distal Target Awl
471793 3.6mm
471794 4.3mm
For Freehand Distal Targeting
Depth Gauge for Crowe Point
Twist Drill
472080
3.6mm Crowe Point Twist Drill (Sterile)
472064
4.3mm Crowe Point Twist Drill (Sterile)
472068
Crowe Point Snap On
Twist Drill (Sterile)
471868 3.6mm
471872 4.3mm
471864 3.2mm
Template
471605
Video
Y-BVP-055V
11
Uniflex®
Titanium Humeral Nail
Titanium Fixaton Screws
4.5mm Diameter /
Fully Threaded
Part Number
Length
Nailing System
Ordering Information
8mm
Diameter
9mm
Diameter
18cm
340618
340718
20cm
22cm
24cm
26cm
28cm
340620
340622
340624
340626
340628
340720
340722
340724
340726
340728
Part Number
Length
345316
345318
345320
345322
345324
345326
345328
345330
345332
345334
345336
345338
345340
345342
345344
345346
16mm
18mm
20mm
22mm
24mm
26mm
28mm
30mm
32mm
34mm
36mm
38mm
40mm
42mm
44mm
46mm
NOTE: 7mm, 10mm and 11mm diameter
nails in lengths of 18cm to 28cm are
available on request.
Titanium End Cap
345220
nstrumentation
Driver Bushing
471620
T-Wrench 3/8" Hex Socket
449110
Driver Bolt
471525
Screw Depth Gauge
34-513644
Target Arm
471530
Twist Drill (Sterile)
472366 3.6mm x 180mm
Driver Handle
471535
Proximal Target
471540
Guide Tube (2 ea.)
471545
Drill Bushing 3.6mm (2 ea.)
471550
Distal Target
471555
3.5mm Hex Drive T-Wrench
457118
12
Nail Extractor Adaptor
471560
Slide Hammer
471565
Nail Driving Guide
3.2mm x 48cm (2 ea.)
467212
6.3mm Medullary Alignment Tube
w/ Ring (Sterile)
469394 Pkg./6
1/4" Step Drill
466365
Instrument Case
592137
SUGGESTED ADDITIONAL
INSTRUMENTATION
Guide Pin Handgrip
469675
469685 Replacement Collet
Drill Bushing Ex-Long 3.6mm (2 ea.)
471552
Guide Tube Ex-Long (2 ea.)
471547
Trocar for Guide Tube
471546
X-Ray Scale
475920
Template
471505
Video
Y-BVP-056V
odular Flexible
Reamer System™
Features
• The Küntscher style head design has proven to provide better venting than many
competitive reamer heads.1,2
• Reversible shaft design provides easier removal intraoperatively.
• One shaft diameter (8mm) for use with all reamer head diameters (8mm-20mm).
• A simple more convenient system that saves time.
• Extra long shaft length (52cm) allows greater distal reaming when necessary.
Reamer Heads
467734 8.0mm
467736 8.5mm
467738 9.0mm
467740 9.5mm
467742 10.0mm
467744 10.5mm
467746 11.0mm
467748 11.5mm
467750 12.0mm
467752 12.5mm
467754 13.0mm
467756 13.5mm
467758 14.0mm
467760 14.5mm
467762 14.0mm
467764 15.5mm
467766 16.0mm
467768 16.5mm
467770 17.0mm
467772 17.5mm
467774 18.0mm
467776 18.5mm
467778 19.0mm
467780 19.5mm
467782 20.0mm
Ti-Nit
Reamer Heads
467634 8.0mm
467636 8.5mm
467638 9.0mm
467640 9.5mm
467642 10.0mm
467644 10.5mm
467646 11.0mm
467648 11.5mm
467650 12.0mm
467652 12.5mm
467654 13.0mm
467656 13.5mm
467658 14.0mm
467660 14.5mm
467662 14.0mm
467664 15.5mm
467666 16.0mm
467668 16.5mm
467670 17.0mm
467672 17.5mm
467674 18.0mm
467676 18.5mm
467678 19.0mm
467680 19.5mm
467682 20.0mm
Reamer Shafts
467716 8.0mm Dia. 40cm Length
469685 8.0mm Dia. 52cm Length
Sterilization Case
593241
Reamer Accessories
469060 3.2mm x 98cm
Ball Tip Guide Wire
476920 Skin Protector
1. Winquist, R.A., Bogosian, A.J., Relationship of Intramedullary Reamer Design to Intramedullary
Pressure and Fat Embolism. Presented at the 61st Annual AAOS, Paper No. 160, 1994.
2. Pape H-C. “Does the Reamer Type Influence the Degree of Lung Dysfunction After Femoral Nailing
Following a Severe Trauma?”, An Animal Study, Journal of Orthopaedic Trauma, 1994; 8(4): 300-309.
Biomet, Inc. Warsaw, IN 46580 (219) 267-6639 ©1998 Biomet, Inc. All Rights Reserved
Biomet Ltd., Waterton Industrial Estate, Bridgend, South Glamorgan CF31 3YN, U.K.
Form No. Y-BMT-451R/093098/H