# 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

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Apr 10, 2008 after 147 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: 10 generations back to K931386 (1993). 75 ancestors in all.
12 later devices descend from it; 1 cites 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)
- K050445: Ams Collagen Dermal Matrix, American Medical Systems, Inc. (2005) Summary page 1.
- K071016: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2007)
- K071065: Orthadapt Bioimplant, Pegasus Biologics, Inc. (2007) Summary page 1.

## Most influential descendants
- K120019: Collagen Ribbon (2012), 11 descendants of its own
- 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

## Indications for use
The WMT Collagen Dermal 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, and other tendons. The WMT Collagen Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. 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/K073219
Methodology: https://510kreport.com/methodology