Class Class II

EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (K251776)

K251776 2025-07-08 Special
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Description

EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) by Encore Medical, L.P., an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251776
Clearance Date2025-07-08
Clearance TypeSpecial
Product CodeJWH
Regulation Number888.3560

Categories

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Predicate lineage for K251776

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 VVC+, e+ Tibial Insert) (K251776) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibia...Encore Medical, L.P Dba Enovis2023

Trace the full predicate network for K251776

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.

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