# K251382: Phoenix Sinus Tarsi Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Orthomed, Inc.
- Decided: Aug 27, 2025 after 117 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 K042030 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142534: HyProCure II, Graham Medical Technologies, LLC Dba Gramedica (2014) Summary page 5.
- K042030: Hyprocure Subtalar Implant System, Graham Medical Technologies, LLC (2004) Summary page 5.

## Indications for use
Phoenix Sinus Tarsi Stent is an implant stabilization device used in the treatment of talotarsal joint instability in adult and pediatric patients four years of age and older. The stent is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.

Source page: https://510kreport.com/device/K251382
Methodology: https://510kreport.com/methodology