# K113399: Ifs Subtalar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Internal Fixation Systems, Inc.
- Decided: Dec 20, 2011 after 33 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 K792670 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032902: Subtalar Arthrorisis Implant, Nexa Orthopedics, Inc. (2003) Summary page 1.
- K031155: Osteomed Subtalar Implant System, Osteomed LP (2003) Summary page 1.

## Indications for use
The IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Source page: https://510kreport.com/device/K113399
Methodology: https://510kreport.com/methodology