# K162310: XBraid TT Suture Tape

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Nov 10, 2016 after 85 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). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150584: Stryker Suture Tape, Stryker (2015) Summary page 5.

## Most influential descendants
- K260775: Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (2026), 0 descendants of its own

## Indications for use
Xbraid TT Suture Tape is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgieries.

Source page: https://510kreport.com/device/K162310
Methodology: https://510kreport.com/methodology