# K213046: AceConnex Pre-Sutured Fascia

- Pathway: 510(k) (Traditional)
- Applicant: Allosource
- Decided: Jun 27, 2023 after 643 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: 5 generations back to K990088 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041553: Arthrex Suture Grafting Kit, Arthrex, Inc. (2004) Summary page 4.

## Indications for use
The AceConnex™ Pre-Sutured Fascia is intended for use as a component in soft tissue surgical procedures where constructs including those with allograft tissues are used for reconstruction, replacement, or augmentation of the hip labrum.

Source page: https://510kreport.com/device/K213046
Methodology: https://510kreport.com/methodology