Class Class II
Phoenix Sinus Tarsi Stent System (K251382)
Description
Phoenix Sinus Tarsi Stent System by Astra Orthomed, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251382
Clearance Date2025-08-27
Clearance TypeTraditional
Product CodeHWC
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251382
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Phoenix Sinus Tarsi Stent System (K251382) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K142534 | HyProCure II | Graham Medical Technologies, LLC Db... | 2014 |
| K111834 | DISCO SUBTALAR IMPLANT | Trilliant Surgical, Ltd. | 2011 |
| K042030 | HYPROCURE SUBTALAR IMPLANT SYSTEM | Graham Medical Technologies, LLC | 2004 |
Trace the full predicate network for K251382
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.