# K053562: Zimmer Collagen Repair Patch

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Science Laboratories, Plc
- Decided: Jun 23, 2006 after 184 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). 29 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021056: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 2.
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2003) Summary page 2.
- K042809: Cuffpatch, Organogenesis, Inc. (2004) Summary page 2.

## Most influential descendants
- K071887: Sportmesh or Artelon Tissue Reinforcement (2007), 28 descendants of its own
- K070961: Biomerix Surgical Mesh, Model: RCR-01 (2008), 17 descendants of its own
- K072370: Surgicraft Surgical Mesh System (2008), 11 descendants of its own
- K192112: FlexBand Plus (2019), 9 descendants of its own
- K083307: Synthasome X-Repair (2009), 9 descendants of its own

## Indications for use
Collagen Repair Patch is intended for the reinforcement of soft tissues which are repaired by sutures or suture anchors, during rotator cuff repair surgery. Collagen Repair Patch is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair. Collagen Repair Patch reinforces soft tissue and provides a scaffold that is eventually incorporated into the patients own soft tissue.

Source page: https://510kreport.com/device/K053562
Methodology: https://510kreport.com/methodology