EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (K251241)
Description
EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) by Encore Medical, L.P., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251241
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. EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (K251241) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240324 | EMPOWR Revision Symmetric Knee Cones | Encore Medical, L.P. (Dba Enovis) | 2024 |
| K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibia... | Encore Medical, L.P Dba Enovis | 2023 |
| K200653 | AMF Revision TT Cones | Lima Corporate S.P.A. | 2020 |
Trace the full predicate network for K251241
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.