# K042809: Cuffpatch

- Pathway: 510(k) (Traditional)
- Applicant: Organogenesis, Inc.
- Decided: Nov 2, 2004 after 21 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: 6 generations back to K921895 (1992). 27 ancestors in all.
72 later devices descend from it; 6 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020049: Fortaflex Surgical Mesh, Organogenesis, Inc. (2002) Summary page 1.
- K011025: Fortaflex Surgical Mesh, Organogenesis, Inc. (2001) Summary page 1.
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K052830: Sportmesh (2006), 44 descendants of its own
- K053562: Zimmer Collagen Repair Patch (2006), 41 descendants of its own
- K051766: Orthomend (2005), 35 descendants of its own
- 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

## Indications for use
CuffPatchTM surgical mesh is intended for 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. CuffPatchTM surgical mesh 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 biomechanical strength for the tendon repair. CuffPatchTM surgical mesh reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue

Source page: https://510kreport.com/device/K042809
Methodology: https://510kreport.com/methodology