# K994202: Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and Spiked Washer System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 25, 2000 after 74 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K871037 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961649: Acufex Tibial Anchor Screw & Spiked Washer, Smith & Nephew Endoscopy, Inc. (1996) Summary page 2.
- K910229: Soft Tissue Suture Washer/3 Hole Washer, Depuy, Inc. (1991) Summary page 2.

## Most influential descendants
- K183628: Arthrex TensionLoc System (2019), 0 descendants of its own

## Indications for use
The Acufex® Washer Systems are indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

Source page: https://510kreport.com/device/K994202
Methodology: https://510kreport.com/methodology