# K231376: Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 9, 2023 after 89 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K990088 (1999). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172165: Q-Fix Suture Anchor, ArthroCare Corporation (2017) Summary page 4.
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 4.

## Indications for use
Q-FIX with Needles use is only intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle • Medial or lateral instability repairs/reconstructions • Achilles tendon repairs/reconstructions

Source page: https://510kreport.com/device/K231376
Methodology: https://510kreport.com/methodology