# K223822: Activbraid™

- Pathway: 510(k) (Traditional)
- Applicant: Embody, Inc.
- Decided: Jun 2, 2023 after 163 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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 K990088 (1999). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112899: Arthrex Bio-Suture, Arthrex, Inc. (2012) Summary page 4.

## Indications for use
ACTIVBRAID™ is indicated for use in soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Source page: https://510kreport.com/device/K223822
Methodology: https://510kreport.com/methodology