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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 / K253592

510(k) cleared

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

Zimmer, Inc. · Apr 13, 2026 · K253592

FDA cleared the Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) from Zimmer, Inc. on Apr 13, 2026 under K253592, a traditional 510(k). The device falls under product code MBF, Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, regulated at 21 CFR 888.3670 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 17, 2025. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zimmer, Inc. has 7 other decisions in the tracker over the last 12 months: K260831 (Z1 Hip System), K261683 (Augment Off-Axis Instrument System), K251840 (Zimmer® Persona® Personalized Knee System), K260182 (Avenir® Müller Stem; Avenir Complete Hip System).

Questions & Answers

What did FDA clear under K253592?

K253592 is the FDA 510(k) for Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter), submitted by Zimmer, Inc.. FDA's decision date was Apr 13, 2026, under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented).

Who makes the Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)?

Zimmer, Inc., based in Warsaw, IN, is the applicant of record for K253592.

How long did the K253592 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Apr 13, 2026, 147 days later.

← All decisions in April 2026