Astra Orthomed, Inc. · Class II · Cleared Aug 27, 2025
| K-number | K251382 |
| Device name | Phoenix Sinus Tarsi Stent System |
| Applicant | Astra Orthomed, Inc. |
| Product code | HWC |
| Device class | Class II |
| Decision date | Aug 27, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Phoenix Sinus Tarsi Stent System is a metallic implant device inserted into the sinus tarsi to stabilize the talotarsal joint in patients with joint instability. It prevents excessive anterior, medial, and/or plantarflexion movement of the talus while permitting normal joint motion, and is indicated for use in adults and pediatric patients aged four years and older.
The device is manufactured from Ti-6Al-4V ELI per ASTM F136 in five sizes with varying diameters, using subtractive manufacturing techniques. It uses the same material as predicate devices, offers sizes within the same ranges, and has only minor geometric differences supported by performance testing.
ASTM F543 (screw pullout testing), ASTM 2193 (cantilever bending), AAMI ST72 and USP <85> (endotoxin), ISO 11137-1 and ISO 11137-2 (sterilization), ISO 10993-5 (cytotoxicity), ISO 11607-1, ASTM F88/F88M, ASTM F2096, and ASTM F1886/1886M (packaging shelf-life performance).
The subject device matches the predicate devices (HyProCure II, HyProCure Subtalar Implant System, and Disco Subtalar Implant) in intended use, design, materials, and mechanical safety. All non-clinical performance testing met predetermined acceptance criteria, and the minor terminology differences in indications for use are clarifications only, not functional changes. The identical material, overlapping size ranges, and identical manufacturing methods with minor geometric variations supported by testing establish substantial equivalence.
View the full FDA submission: accessdata.fda.gov