# K061892: Propatch Soft Tissue Repair Matrix

- Pathway: 510(k) (Abbreviated)
- Applicant: Cryolife, Inc.
- Decided: Nov 22, 2006 after 142 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: 7 generations back to K921895 (1992). 28 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043388: Pegasus Biologics Orthadapt Surgical Mesh, Pegasus Biologics, Inc. (2005) Summary page 1.
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K982330: Depuy Orthotech Restore Orthobiologic Soft Tissue Implant, Depuy, Inc. (1998) Summary page 1.

## Most influential descendants
- K071016: Depuy Restore Orthobiologic Soft Tissue Implant (2007), 13 descendants of its own
- 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 (2008), 12 descendants of its own
- 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

## Indications for use
ProPatch Soft Tissue Repair Matrix is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. ProPatch Soft Tissue Repair Matrix is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. ProPatch Soft Tissue Repair 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 sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. ProPatch Soft Tissue Repair Matrix reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient’s own soft tissue.

Source page: https://510kreport.com/device/K061892
Methodology: https://510kreport.com/methodology