# K101587: Propatch Soft Tissue Repair Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Cryolife, Inc.
- Decided: Sep 16, 2010 after 101 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: 8 generations back to K921895 (1992). 29 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061892: Propatch Soft Tissue Repair Matrix, Cryolife, Inc. (2006) Summary page 1.

## Most influential descendants
- K113460: Synergy Tissue Matrix (2012), 0 descendants of its own
- K110581: Propatch Soft Tissue Repair Matrix (2012), 0 descendants of its own

## Indications for use
Non-Joint Related Repair ProPatch 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. Joint Related Repair ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

Source page: https://510kreport.com/device/K101587
Methodology: https://510kreport.com/methodology