# K150309: Extremity Medical Calcaneal Osteotomy Device

- Pathway: 510(k) (Special)
- Applicant: Extremity Medical, LLC
- Decided: Mar 4, 2015 after 23 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: 8 generations back to K962823 (1996). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143402: Extremity Medical Calcaneal Osteotomy Device, Extremity Medical, LLC (2015) Summary page 4.

## Indications for use
The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.

Source page: https://510kreport.com/device/K150309
Methodology: https://510kreport.com/methodology