# K150213: Subtalar Spacer System (STS)

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 8, 2015 after 98 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032682: STS Screw, Ortho-Pro, LLC (2003) Summary page 4.
- K070441: Metasurg Subtalar Implant, Metasurg (2007) Summary page 4.

## Indications for use
The STS screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. » Severely pronated foot; » Walking intemperance; » Calcaneal stance position greater than 5°; * Manually correctable deformities; + Mid-tarsal breech (arch pain); * Forefoot varus greater than 10°.

Source page: https://510kreport.com/device/K150213
Methodology: https://510kreport.com/methodology