# K910229: Soft Tissue Suture Washer/3 Hole Washer

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jul 24, 1991 after 187 days
- Product code: HTN (Washer, Bolt Nut)
- 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K994202: Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and Spiked Washer System (2000), 1 descendant of its own
- K183628: Arthrex TensionLoc System (2019), 0 descendants of its own
- K991135: Soft Tissue Suture Washer (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K910229
Methodology: https://510kreport.com/methodology