# K110581: Propatch Soft Tissue Repair Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Cryolife, Inc.
- Decided: Jan 10, 2012 after 315 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: 9 generations back to K921895 (1992). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101587: Propatch Soft Tissue Repair Matrix, Cryolife, Inc. (2010) Summary page 1.

## Indications for use
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. ProPatch is indicated for reinforcement where weakness exists, 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/K110581
Methodology: https://510kreport.com/methodology