Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EMPOWR Knee

K-Number: K252974 · 2025-12-19

ApplicantEncore Medical L.P.
Decision Date2025-12-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPOWR Knee is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252974. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPOWR Knee?

EMPOWR Knee is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Encore Medical L.P.. The 510(k) number is K252974.

When did EMPOWR Knee receive FDA 510(k) clearance?

EMPOWR Knee received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252974.

Who is the listed applicant for EMPOWR Knee?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPOWR Knee?

The FDA product code for EMPOWR Knee is JWH.

Other records listing Encore Medical L.P. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252567AltiVate Reverse® ADLC GlenosphereK251833EMPOWR Acetabular® Liner ExtensionK252141AltiVate Reverse® GlenoidK251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System

View all 31 devices →

Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑