# K093055: CSTS Screw

- Pathway: 510(k) (Traditional)
- Applicant: Orthopro, LLC
- Decided: Nov 22, 2010 after 418 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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 1.
- K032902: Subtalar Arthrorisis Implant, Nexa Orthopedics, Inc. (2003) Summary page 1.

## Most influential descendants
- K170624: TalarLift STS (2017), 0 descendants of its own

## Indications for use
The Ortho-Pro CSTS 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 * Calcaneal stance position greater than 50 * Manually correctable deformities * Mid-tarsal breech (arch pain) * Forefoot varus greater than 100

Source page: https://510kreport.com/device/K093055
Methodology: https://510kreport.com/methodology