# K152868: ExpressBraid Graft Manipulation

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Feb 8, 2016 after 131 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: 8 generations back to K904436 (1990). 32 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122374: Arthrex Suture (Uhmwpe), Arthrex, Inc. (2012) Summary page 4.

## Most influential descendants
- K163651: ExpressBraid Graft Manipulation (2017), 0 descendants of its own
- K160854: MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture (2016), 0 descendants of its own

## Indications for use
The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

Source page: https://510kreport.com/device/K152868
Methodology: https://510kreport.com/methodology
