Class Class II
Incompass Total Ankle System (K250037)
Description
Incompass Total Ankle System by Wright Medical Technology, Inc. (Stryker), an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250037
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeHSN
Regulation Number888.3110
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250037
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. Incompass Total Ankle System (K250037) cites 11 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle S... | Wrightmedicaltechnologyinc | 2020 |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc | 2019 |
| K181557 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018 |
| K172633 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | 2018 |
| K140749 | INFINITY TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | 2014 |
| K133585 | INBONE TOTAL ANKLE | Wrightmedicaltechnologyinc | 2014 |
| K123954 | INFINITY TOTAL ANKLE SYSTEM | Wrightmedicaltechnologyinc | 2013 |
| K123059 | INBONE ( I AND II) TOTAL ANKLE SYSTEMS | Wrightmedicaltechnologyinc | 2013 |
| K110360 | PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | Wrightmedicaltechnologyinc | 2011 |
| K053569 | AGILITY LP TOTAL ANKLE PROSTHESIS | DePuy Orthopaedics, Inc. | 2006 |
| K051023 | TOPEZ TOTAL ANKLE REPLACEMENT | Topez Orthopedics, Inc. | 2005 |
Trace the full predicate network for K250037
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.