# K143402: Extremity Medical Calcaneal Osteotomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Feb 4, 2015 after 68 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: 7 generations back to K962823 (1996). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121349: IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer, Extremity Medical, LLC (2012) Summary page 4.
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 4.
- K124022: Speed Shift, Biomedical Enterprises, Inc. (2013) Summary page 4.

## Most influential descendants
- K150309: Extremity Medical Calcaneal Osteotomy Device (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K143402
Methodology: https://510kreport.com/methodology