# K032682: STS Screw

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Pro, LLC
- Decided: Oct 22, 2003 after 54 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.
3 later devices descend from it; 3 cite it directly.
0 of 6 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
- K093055: CSTS Screw (2010), 1 descendant of its own
- K170624: TalarLift STS (2017), 0 descendants of its own
- K150213: Subtalar Spacer System (STS) (2015), 0 descendants of its own

## Indications for use
The Ortho-Pro 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. It is appropriate for the following conditions: 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/K032682
Methodology: https://510kreport.com/methodology