# K250109: TYBR Collagen Gel

- Pathway: 510(k) (Traditional)
- Applicant: Tybr Health
- Decided: Jun 6, 2025 after 141 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: 6 generations back to K000019 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213163: VersaWrap, Alafair Biosciences, Inc. (2021) Summary page 5.
- K162570: Miromatrix Biological Mesh TW, Miromatrix Medical, Inc. (2017) Summary page 5.

## Indications for use
TYBR Collagen Gel is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.

Source page: https://510kreport.com/device/K250109
Methodology: https://510kreport.com/methodology