# K240817: VersaWrap

- Pathway: 510(k) (Traditional)
- Applicant: Alafair Biosciences, Inc.
- Decided: Jun 14, 2024 after 81 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: 6 generations back to K000019 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K251655: VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (2025), 0 descendants of its own

## Indications for use
VersaWrap 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 ligaments. In these procedures, VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples, and sutures.

Source page: https://510kreport.com/device/K240817
Methodology: https://510kreport.com/methodology