Class Class II
Mfinity Femoral System (K251166)
Description
Mfinity Femoral System by Medacta International S.A., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251166
Clearance Date2025-06-13
Clearance TypeTraditional
Product CodeMEH
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251166
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. Mfinity Femoral System (K251166) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021 |
| K192827 | Quadra-P | Medacta International S.A. | 2020 |
| K181254 | Quadra P | Medacta International S.A. | 2018 |
| K173794 | AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared | Medacta International S.A. | 2018 |
| K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy(Ireland) | 2016 |
| K151531 | MasterLoc Stem | Medacta International | 2015 |
| K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 |
Trace the full predicate network for K251166
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.