# K243843: Tendon Protect (50242)

- Pathway: 510(k) (Traditional)
- Applicant: Kerecis Limited
- Decided: Jun 4, 2025 after 173 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 K921895 (1992). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053655: Tendon Wrap Tendon Protector, Integra LifeSciences Corporation (2006) Summary page 5.
- K202430: Kerecis Reconstruct, Kerecis Limited (2021) Summary page 5.

## Indications for use
Kerecis Tendon Protect 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/K243843
Methodology: https://510kreport.com/methodology