# K103797: K2M Cocr Wire

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: May 20, 2011 after 144 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- 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 K031127 (2003). 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)
- K031127: Orthopedic Wire, Howmedica Osteonics Corp. (2003)

## Indications for use
K2M CoCr Wires are intended for: * Bone fracture fixation * Osteotomy * Arthrodesis * Correction of deformity * Revision procedures when other treatments or devices have been unsuccessfuhl, and, * Bone reconstruction procedures

Source page: https://510kreport.com/device/K103797
Methodology: https://510kreport.com/methodology