# K113460: Synergy Tissue Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Orthopedic & Woundcare
- Decided: Jan 11, 2012 after 50 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 K842066 (1985). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 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.
- K071065: Orthadapt Bioimplant, Pegasus Biologics, Inc. (2007)
- K030879: Veritas Collagen Matrix, Synovis Surgical Innovations (2003) Summary page 1.
- K062915: Veritas Collagen Matrix, Synovis Surgical Innovations (2006) Summary page 1.
- K042809: Cuffpatch, Organogenesis, Inc. (2004) Summary page 1.
- K061892: Propatch Soft Tissue Repair Matrix, Cryolife, Inc. (2006) Summary page 1.
- K101587: Propatch Soft Tissue Repair Matrix, Cryolife, Inc. (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K002233: Bvi Sling, Bio-Vascular, Inc. (2000). Our reading of the summary gave K002233, FDA’s number for Bvi Sling (Bio-Vascular, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Veritas® Collagen Matrix”. Kept off the family tree. Summary page 1.

## Indications for use
Synergy Tm Tissue Matrix is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Synergy Tissue 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 biomnechanical strength for the tendon repair.

Source page: https://510kreport.com/device/K113460
Methodology: https://510kreport.com/methodology