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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K252974

510(k) cleared

EMPOWR Knee

Encore Medical L.P. · Dec 19, 2025 · K252974

FDA cleared the EMPOWR Knee from Encore Medical L.P. on Dec 19, 2025 under K252974, a traditional 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 17, 2025. The decision came 93 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Encore Medical L.P. has 2 other decisions in the tracker over the last 12 months: K252567 (AltiVate Reverse® ADLC Glenosphere), K251833 (EMPOWR Acetabular® Liner Extension).

Questions & Answers

What did FDA clear under K252974?

K252974 is the FDA 510(k) for EMPOWR Knee, submitted by Encore Medical L.P.. FDA's decision date was Dec 19, 2025, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the EMPOWR Knee?

Encore Medical L.P., based in Austin, TX, is the applicant of record for K252974.

How long did the K252974 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Dec 19, 2025, 93 days later.

← All decisions in December 2025

Sources