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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 / November 2025 / K251833

510(k) cleared

EMPOWR Acetabular® Liner Extension

Encore Medical L.P. · Nov 12, 2025 · K251833

FDA cleared the EMPOWR Acetabular® Liner Extension from Encore Medical L.P. on Nov 12, 2025 under K251833, a traditional 510(k). The device falls under product code LPH, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, regulated at 21 CFR 888.3358 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 16, 2025. The decision came 149 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), K252974 (EMPOWR Knee).

Questions & Answers

What did FDA clear under K251833?

K251833 is the FDA 510(k) for EMPOWR Acetabular® Liner Extension, submitted by Encore Medical L.P.. FDA's decision date was Nov 12, 2025, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the EMPOWR Acetabular® Liner Extension?

Encore Medical L.P., based in Austin, TX, is the applicant of record for K251833.

How long did the K251833 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Nov 12, 2025, 149 days later.

← All decisions in November 2025

Sources