# K140283: Osteomed Extremifuse System

- Pathway: 510(k) (Special)
- Applicant: Osteomed
- Decided: Feb 28, 2014 after 24 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: 4 generations back to K013888 (2002). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130412: Osteomed Extremifuse System, Osteomed (2013) Summary page 1.
- K111536: Metasurg Digifuse Implant, Metasurg (2011) Summary page 1.
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 1.
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System, Osteomed LP (2006) Summary page 2.

## Indications for use
The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Source page: https://510kreport.com/device/K140283
Methodology: https://510kreport.com/methodology