# K961585: Surgical Dynamics Pop Rivet

- 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 K951658 (1995). 1 ancestor in all.
28 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951658: Lactosorb Pop Rivet, Poly-Medics,Inc. (1995) Summary page 1.

## Most influential descendants
- K071920: Autosuture Absorbable Tack and Applicator (2007), 26 descendants of its own
- K091900: Absorbatack 5MM Single Use Absorbable Fixation Device (2009), 12 descendants of its own
- K090470: Autosuture Protack; Tacker System; Absorbatack Fixation Devices (2009), 12 descendants of its own
- K093845: Ethicon Securestrap 5MM Absorbable Strap Fixation Device, Model STRAP25 (2010), 11 descendants of its own
- K123109: Absorbatack 5MM Single Use Absorbable Fixation Device (2012), 4 descendants of its own

## Indications for use
Both the Surgical Dynamics™ Pop Rivet*™ and the Poly-Medics Lactosorb® Pop Rivet (K951658) are indicated for use in soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with recurrent anterior dislocation or subluxation of the shoulder.

Source page: https://510kreport.com/device/K961585
Methodology: https://510kreport.com/methodology