# K031155: Osteomed Subtalar Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Aug 22, 2003 after 133 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: 2 generations back to K792670 (1980). 2 ancestors in all.
16 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960692: Subtalar Mba System, Kinetikos Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K080280: Sub-Talar Lok, Model 7-11 MM (2008), 12 descendants of its own
- K093820: Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 (2010), 8 descendants of its own
- K103183: Trilliant Surgical Subtalar Implant (2011), 4 descendants of its own
- K111834: Disco Subtalar Implant (2011), 3 descendants of its own
- K133035: Normed Pellegrin Calcaneus Stop Screw (2013), 2 descendants of its own

## Indications for use
Indicated for use in the treatment of the 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 blocking excessive pronation and the resulting sequela. OsteoMed Subtalar Implants are intended for single use only.

Source page: https://510kreport.com/device/K031155
Methodology: https://510kreport.com/methodology