# K120019: Collagen Ribbon

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 23, 2012 after 51 days
- Product code: FTM (Mesh, Surgical)
- 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: 11 generations back to K931386 (1993). 76 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073219: WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6 CM X 8 CM, Model 89XM-6X08, American Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K131143: Trellis Collagen Ribbon (2013), 10 descendants of its own
- K151083: BioBridge Collagen Matrix (2016), 9 descendants of its own
- 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

## Indications for use
The Collagen Ribbon Tissue Matrix is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, peroneal, posterial tibial, and other tendons. The Collagen Ribbon Tissue Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair. Sutures used to repair the tear and suture or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Source page: https://510kreport.com/device/K120019
Methodology: https://510kreport.com/methodology