# K081122: Fusion Medical Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: John Riccio
- Decided: May 26, 2009 after 400 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) Osteomed: named in the summary without a submission number

## Indications for use
For bone fixation of foot and ankle surgery and hand surgery, following a trauma or osteotomy. Screws and washers are intended for single use only

Source page: https://510kreport.com/device/K081122
Methodology: https://510kreport.com/methodology