# K041333: Synthes (Usa) Titanium Wire

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 27, 2004 after 100 days
- Product code: GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile)
- Device class: 2
- Regulation: 21 CFR 878.4495
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ethicon, Inc. Ethilon Nylon Suture: named in the summary without a submission number

## Most influential descendants
- K183472: DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional (2019), 0 descendants of its own

## Indications for use
Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair.

Source page: https://510kreport.com/device/K041333
Methodology: https://510kreport.com/methodology
