# K130412: Osteomed Extremifuse System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed
- Decided: May 31, 2013 after 101 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: 3 generations back to K013888 (2002). 11 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101165: Pro-Toe VO Hammertow Implant System, Wrightmedicaltechnologyinc (2010) Summary page 1.
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 3.
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System, Osteomed LP (2006) Summary page 1.

## Most influential descendants
- K133515: Peek Fusion Implant (2014), 2 descendants of its own
- K211996: Nexta PEEK Hammertoe Correction System (2021), 0 descendants of its own
- K140970: One-Piece Peek Fusion Implant (2014), 0 descendants of its own
- K140283: Osteomed Extremifuse System (2014), 0 descendants of its own

## 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/K130412
Methodology: https://510kreport.com/methodology