BIOFIBER™
Absorbable Scaffold
BIOFIBER™ CM
Collagen Coated
Absorbable Scaffold
A B S O R B A B L E
A M BBI EI N
T T EM P ER AT U R
O L O G I C
A FN FDO CL RDYI ON PGR E S E R V E
S C A
S O S
L T
UO
TR
I A
O G
N ES O P T I O N
What is BIOFIBER™?
An advancement in orthopedic absorbable polymers,
BIOFIBER™ is the first orthopedic soft tissue scaffold
that:
• Reinforces the suture-tendon interface
• Mechanically reinforces tendon repairs
•D
esigned for tissue in-growth utilizing an improved
biocompatible polymer
•M
ade from P4HB – A non-synthetic fermented
polymer that breaks down into natural occurring
metabolites
• Overlay
• Grommet support
What is BIOFIBER™ - CM?
• Mid-substance
reinforcement
BIOFIBER™- Collagen Matrix is comprised of the same
P4HB material with the addition of a type 1 bovine
collagen coating which increases vascularization and
cell density at the site of repair.
• Provides long-term support while serving as a
biocompatible scaffold for host tissue ingrowth
• Distributes tissue loads during the healing process
while allowing for return of natural tendon
attachment to bone
• Provides support during healing to permit return to
normal joint mechanics
• Designed to provide support to damaged soft tissue to
maintain structural integrity
BIOFIBER™
ABSORBABLE BIOLOGIC SCAFFOLD FOR
S O F T T I S S U E R E PA I R A N D R E I N F O R C E M E N T
Why Reinforce?
•H
igh failure rates for older patients or
patients with thin, weak tendons
• High failure rates for larger tears
• Patients with comorbid conditions
• Suture line tears
•T
issue that forms post repair is
mechanically weaker than native tissue
Strengthen Repairs
High tensile and suture
retention strength
Resorbable, biologically
derived fiber
Dense, bi-layer weave designed
to provide mechanical
properties in all directions
Ability to “wick” and hold blood
BIOFIBER™ Applications
BIOFIBER™ is available in multiple shapes and sizes
which allows for a wide range of indications and
repairs using a simple and fast surgical technique.
Shoulder
Foot/Ankle
Knee
• Rotator cuff
repair
• Small tears
• Medium tears
• Subscapularis
repair
• Achilles
tendon repair
• Retrocalcaneal
enthesiopathy
• Lateral ankle
instability
• Quadriceps
tendon repair
• Patellar
tendon repair
Suture Retention Strength (N)
BIOFIBER™ Reinforced Tendon: 73%
Increase in Suture Retention vs. Control
Suture Retention**
300
120
250
100
110.0
80
200
60
150
40
100
65.1
216
182
50
20
0
229
Control
BIOFIBER™
Average suture retention strength for
BIOFIBER™ reinforced tendons was
110 N and the control tendons were
65 N which is an increase of 73 ± 37%
(p < 0.0001)
0
GRAFTJACKET™ BIOFIBER™* GRAFTJACKET™
MaxForce Extreme
MaxForce
Data on file at Wright
Barber, A. et al. Tendon augmentation grafts:
biomechanical failure loads and failure patterns.
Arthroscopy: The Journal of Arthroscopic and
Related Surgery. 2006; 22-5: 534-538.
* BIOFIBER™(3 cm x 3 cm)
**Mattress stitch 5 mm or more from an edge
General Information
Material
Poly-4-hydroxybutyrate (P4HB)
Strength216N*
Thickness
1 mm
Resorption Time
12-18 months
Sterility 10-6 SAL
Shelf Life
2 years
Biomechanical
Properties
Engineered to internally reinforce the suture
line and internally reinforce the tendon
Biologic
Properties
Non-synthetic polymer that breaks down to a
natural occurring metabolite allowing healing
without inflammation
* Mattress stitch 5mm or more from an edge
Special leno weave designed
to prevent fraying
High
strength yet elastic
to share the load with
in-growing tissue
Edges ultrasonically cut for
strength and consistency
Porous design to encourage
tissue in-growth
BIOFIBER™ Product Codes
Product Item No.
Description
Discs: 8 mm each (2 discs/unit box)
BFR100101
Box of 1
BBF0008DU
Box of 4
Strips: 13 mm x 23 mm (1 strip/unit box)
BFR100201
Box of 1
BBF1323SU
Box of 4
BIOFIBER™ - CM Product Codes
Product Item No.
Description
Strips: 20 mm x 30 mm (1 strip/unit box)
BFR100302
Box of 1
BIOFIBER™ Facility Reimbursement
HCPCS Code – Hospital
Q4100 Skin substitute, not otherwise specified
HCPCS Code – Ambulatory Surgery Center
L8699 Prosthetic implant, not otherwise specified
1023 Cherry Road
Memphis, TN 38117
800 238 7117
901 867 9971
www.wright.com
10801 Nesbitt Avenue South
Bloomington, MN 55437
888 867 6437
952 426 7600
www.tornier.com
™ and ® denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates.
©2016 Wright Medical Group N.V. or its affiliates. All Rights Reserved.
CAW-5603 REV B ECN 160817 27-Jun-2016