# K973281: The Surgical Dynamics* S.D. Sorb* E-Z Tac*

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Nov 3, 1997 after 62 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- 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 K951658 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961585: Surgical Dynamics Pop Rivet, United States Surgical, A Division of Tyco Healthc (1996) Summary page 1.
- K961578: Suture Anchor, United States Surgical, A Division of Tyco Healthc (1996) Summary page 1.
- K953877: Mitek Gii Anchor, Mitek Surgical Products, Inc. (1995) Summary page 1.

## Indications for use
The Surgical Dynamics® SeD sorb® E-Z Tac® is indicated for use in soft tissue to bone fixation for rotator cuff repairs and reattachment of the glenoid labrum and/or inferior glenohumeral ligament.

Source page: https://510kreport.com/device/K973281
Methodology: https://510kreport.com/methodology