# K964243: Humerus Wires

- Pathway: 510(k) (Traditional)
- Applicant: Compagnie Financiere & Medicale (Cf&M)
- Decided: Dec 5, 1996 after 42 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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 K811002 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902264: True/Flex Humerus, Ulna and Radius Intramedullary, Applied Osteo Systems, Inc. (1990) Summary page 1.
- K913949: True/Flex Humerus, Ulna & Radius Intramed Rods Sys, Applied Osteo Systems, Inc. (1992) Summary page 1.
- K811002: Ender Pins, Richard'S Medical Equip., Inc. (1981) Summary page 1.
- K905341: Rush Pin, O'Tec Corp. (1990) Summary page 1.
- K903261: Rush Pin, Onyx Medical Corp. (1990) Summary page 1.

## Indications for use
The Humerus Wires device is intended to be implanted in the humerus for internal fixation of fractures and/or reconstruction of the humeral bone.

Source page: https://510kreport.com/device/K964243
Methodology: https://510kreport.com/methodology