# K961578: Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Jul 10, 1996 after 77 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 K954443 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954443: Lactosorb Suture Anchor, Poly-Medics,Inc. (1996) Summary page 1.

## Most influential descendants
- K973281: The Surgical Dynamics* S.D. Sorb* E-Z Tac* (1997), 0 descendants of its own

## Indications for use
Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are indicated for attachment of soft tissue to bone in shoulder, wrist and hand procedures

Source page: https://510kreport.com/device/K961578
Methodology: https://510kreport.com/methodology