# K163034: SUTUREFIX Curved Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Smith and Nephew, Inc.
- Decided: Dec 7, 2016 after 37 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: 6 generations back to K961555 (1996). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122059: All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture Anchors, Smith & Nephew, Inc. (2013) Summary page 4.
- K102660: Bioraptor Curved 2.3 PK Suture Anchors, Smith & Nephew Endoscopy, Inc. (2010) Summary page 4.

## Indications for use
The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications: Hip • Acetabular labrum repair/reconstruction Shoulder • Capsular stabilization – Bankart repair – Anterior shoulder instability – SLAP lesion repairs – Capsular shift or capsulolabral reconstructions – Rotator cuff tear repairs – Bicepts tenodesis

Source page: https://510kreport.com/device/K163034
Methodology: https://510kreport.com/methodology