# K251655: VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)

- Pathway: 510(k) (Traditional)
- Applicant: Alafair Biosciences
- Decided: Jul 18, 2025 after 49 days
- Product code: OWW (Mesh, Surgical, 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: 7 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)
- K240817: VersaWrap, Alafair Biosciences, Inc. (2024) Summary page 5.

## Indications for use
VersaCoat Tendon Protector 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 to manage and protect surrounding tissues such as ligament and skeletal muscle. In these procedures, the device may encounter implanted structures such as anchors, grafts, staples, or sutures.

Source page: https://510kreport.com/device/K251655
Methodology: https://510kreport.com/methodology