# K020948: Smith & Nephew Suretac - Expanded Indications II

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 9, 2002 after 198 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: 1 generation back to K911837 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
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). Our reading of the summary gave K931819, FDA’s number for Carapace Suture Removal Trays (Carapace, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SURETAC Expanded Indication”.

## Most influential descendants
- K023417: Suretac Iii, Models 7209900, 7209901 (2002), 0 descendants of its own

## Indications for use
Indicated for use in Rotator Cuff Repair

Source page: https://510kreport.com/device/K020948
Methodology: https://510kreport.com/methodology