# K070961: Biomerix Surgical Mesh, Model: RCR-01

- Pathway: 510(k) (Traditional)
- Applicant: Biomerix Corporation
- Decided: Feb 25, 2008 after 326 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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). 48 ancestors in all.
17 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K052830: Sportmesh, Artimplant AB (2006) Summary page 1.
- K053562: Zimmer Collagen Repair Patch, Tissue Science Laboratories, Plc (2006) Summary page 1.
- K043371: Biomerix Vascular Occlusion Device and Loader, Biomerix Corporation (2005) Summary page 1.
- (no number) Ethicon Mersilene Polyester Fiber Mesh: named in the summary without a submission number

## Most influential descendants
- K072370: Surgicraft Surgical Mesh System (2008), 11 descendants of its own
- K090288: Orthadapt PR (2009), 7 descendants of its own
- K112786: Proseries Bioimplants-Proankle/Procuff (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K082941: Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215 (2009), 3 descendants of its own

## Indications for use
The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery. The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair

Source page: https://510kreport.com/device/K070961
Methodology: https://510kreport.com/methodology