# K243480: SuturePatch Tissue Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: May 29, 2025 after 202 days
- Product code: OWX (Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon)
- 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). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070961: Biomerix Surgical Mesh, Model: RCR-01, Biomerix Corporation (2008) Summary page 5.
- K122374: Arthrex Suture (Uhmwpe), Arthrex, Inc. (2012) Summary page 5.
- K190707: Arthrex SoftStitch, Arthrex, Inc. (2020) Summary page 5.

## Indications for use
The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement 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. The SuturePatch Tissue Reinforcement device reinforces and protects healing soft tissues. The SuturePatch Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support 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 bone, provide mechanical strength for the repair.

Source page: https://510kreport.com/device/K243480
Methodology: https://510kreport.com/methodology