# K991135: Soft Tissue Suture Washer

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Apr 29, 1999 after 24 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
Longest line of descent: 1 generation back to K910229 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910229: Soft Tissue Suture Washer/3 Hole Washer, Depuy, Inc. (1991) Summary page 1.

## Indications for use
To provide fixation to bone of the tibial and/or femoral end of a bone-patellar tendon-bone graft or other soft tissue graft material used to reconstruct the ACL and/or PCL in an intra-articular procedure of the knee.

Source page: https://510kreport.com/device/K991135
Methodology: https://510kreport.com/methodology