# K112658: Osteospring Footjack Subtalar Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osteospring Medical, Inc.
- Decided: Dec 12, 2011 after 90 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 K792670 (1980). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031155: Osteomed Subtalar Implant System, Osteomed LP (2003) Summary page 1.
- K080280: Sub-Talar Lok, Model 7-11 MM, Instratek, Inc. (2008) Summary page 1.
- K070441: Metasurg Subtalar Implant, Metasurg (2007) Summary page 1.

## Indications for use
The OsteoSpring FootJack M Subtalar Implant System is indicated for use in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System implants are intended for single patient use only.

Source page: https://510kreport.com/device/K112658
Methodology: https://510kreport.com/methodology