# K972599: Acufex  Screw Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Sep 19, 1997 after 67 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 K915424 (1993). 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)
- K915424: Arthrex Cannulated Interference Screw, Arthrex, Inc. (1993) Summary page 1.

## Indications for use
The Acufex Screw Cannula is used for fixation of bone-tendon-bone grafts during Anterior or Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.

Source page: https://510kreport.com/device/K972599
Methodology: https://510kreport.com/methodology