# K023417: Suretac Iii, Models 7209900, 7209901

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 7, 2002 after 27 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911837 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911837: Suretac Polyglyconate Absorbable Fixation Device, Acufex Microsurgical, Inc. (1991) Summary page 1.
- K931519: Acufex Suretac, Acufex Microsurgical, Inc. (1994) Summary page 1.
- K020948: Smith & Nephew Suretac - Expanded Indications II, Smith & Nephew, Inc. (2002) Summary page 1.

## Indications for use
The SURETAC I11 is indicated for rotator cuff repair, repair of recurrent anterior shoulder dislocation and subluxaton, and repair of acute/primary anterior shoulder dislocation and subluxation.

Source page: https://510kreport.com/device/K023417
Methodology: https://510kreport.com/methodology