# K151083: BioBridge Collagen Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Fibralign Corporation
- Decided: Jan 8, 2016 after 261 days
- Product code: OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K931386 (1993). 92 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131143: Trellis Collagen Ribbon, Wrightmedicaltechnologyinc (2013) Summary page 5.
- K120019: Collagen Ribbon, Wrightmedicaltechnologyinc (2012) Summary page 5.
- K142326: HP Tissue Matrix, Lifecell Corporation (2014) Summary page 5.
- K082176: LTM-BPS Surgical Mesh, Lifecell Corp. (2008) Summary page 6.

## Most influential descendants
- K222978: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K230316: FlexBand; FlexPatch; FlexBand Plus (2023), 3 descendants of its own
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), 2 descendants of its own
- K261621: TekBrace Solo Soft Tissue Reinforcement Device (2026), 1 descendant of its own
- K242187: BioBrace® (2024), 1 descendant of its own

## Indications for use
The BioBridge™ Collagen Matrix is intended to reinforce soft tissue where weakness and deficiencies exist, specifically, for reinforcement of soft tissue repaired by sutures or suture anchors in tendon repair, including small tendons, ligaments, and general surgical procedures for tissue repair where weakness exists, including muscle flap reinforcement. BioBridge is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair,

Source page: https://510kreport.com/device/K151083
Methodology: https://510kreport.com/methodology