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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 / January 2026 / K252516

510(k) cleared

N22 EZ Glenosphere

Shoulder Innovations, Inc. · Jan 15, 2026 · K252516

FDA cleared the N22 EZ Glenosphere from Shoulder Innovations, Inc. on Jan 15, 2026 under K252516, 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 Aug 11, 2025. The decision came 157 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shoulder Innovations, Inc. has 2 other decisions in the tracker over the last 12 months: K254128 (InSet Reverse Total Shoulder System), K252221 (Inset Reverse Total Shoulder System).

Questions & Answers

What did FDA clear under K252516?

K252516 is the FDA 510(k) for N22 EZ Glenosphere, submitted by Shoulder Innovations, Inc.. FDA's decision date was Jan 15, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the N22 EZ Glenosphere?

Shoulder Innovations, Inc., based in Grand Rapids, MI, is the applicant of record for K252516.

How long did the K252516 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Jan 15, 2026, 157 days later.

← All decisions in January 2026

Sources