# K242631: REGENETEN™ Bioinductive Implant

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Div.
- Decided: Nov 26, 2024 after 84 days
- Product code: OWY (Mesh, Surgical, Collagen, 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: 8 generations back to K850785 (1985). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222501: Regeneten Bioinductive Implant, Smith and Nephew, Inc. (2023) Summary page 5.

## Indications for use
The REGENETEN Bioinductive* Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue. * Bioinductivity has been demonstrated for tendon only. The REGENETEN Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN Bioinductive Implant.

Source page: https://510kreport.com/device/K242631
Methodology: https://510kreport.com/methodology