# K965073: 9 X 25MM Standard Interfernece Scre (S.I.S.) Acl Screw

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 27, 1997 after 70 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Arthrex Inc. Cannulated Sheathed Interference Screw: named in the summary without a submission number
- (no number) Concept, Inc. Cannulated Conical Tip Interference Screw: named in the summary without a submission number
- (no number) Depuy Kurosaka Fixation Screw: named in the summary without a submission number
- (no number) Smith & Nephew RCI ACL Fixation Screw: named in the summary without a submission number

Source page: https://510kreport.com/device/K965073
Methodology: https://510kreport.com/methodology