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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 / April 2026 / K252404

510(k) cleared

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

Biomet Orthopedics · Apr 15, 2026 · K252404

FDA cleared the Comprehensive Reverse Shoulder - HA Glenosphere Baseplates from Biomet Orthopedics on Apr 15, 2026 under K252404, a traditional 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 31, 2025. The decision came 258 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Biomet Orthopedics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252404?

K252404 is the FDA 510(k) for Comprehensive Reverse Shoulder - HA Glenosphere Baseplates, submitted by Biomet Orthopedics. FDA's decision date was Apr 15, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the Comprehensive Reverse Shoulder - HA Glenosphere Baseplates?

Biomet Orthopedics, based in Warsaw, IN, is the applicant of record for K252404.

How long did the K252404 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Apr 15, 2026, 258 days later.

← All decisions in April 2026