# K222501: Regeneten Bioinductive Implant

- Pathway: 510(k) (Traditional)
- Applicant: Smith and Nephew, Inc.
- Decided: May 11, 2023 after 266 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: 7 generations back to K850785 (1985). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140300: Collagen Tendon Sheet-Ddi (CTS-Ddi), Rotation Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K242187: BioBrace® (2024), 1 descendant of its own
- K252946: BioBrace® Extra-Articular Ligament Augmentation Kit (2025), 0 descendants of its own
- K242631: REGENETEN™ Bioinductive Implant (2024), 0 descendants of its own

## Indications for use
Regeneten Bioinductive Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Source page: https://510kreport.com/device/K222501
Methodology: https://510kreport.com/methodology