# K961649: Acufex Tibial Anchor Screw & Spiked Washer

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Jul 16, 1996 after 77 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: 1 generation back to K871037 (1987). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K871037: Cancellous Fixation Screw & Washer for Use W/Screw, Concept, Inc. (1987) Summary page 1.
- (no number) Synthes® Spiked Washer: named in the summary without a submission number

## 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
- K983906: Depuy Orthotech Spiked Washer (1998), 0 descendants of its own

## Indications for use
The Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures.

Source page: https://510kreport.com/device/K961649
Methodology: https://510kreport.com/methodology