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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 / K252352

510(k) cleared

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System

Lima Corporate S.P.A. · Jan 22, 2026 · K252352

FDA cleared the SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System from Lima Corporate S.P.A. on Jan 22, 2026 under K252352, 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 29, 2025. The decision came 177 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 Lima Corporate S.P.A. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252352?

K252352 is the FDA 510(k) for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System, submitted by Lima Corporate S.P.A.. FDA's decision date was Jan 22, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

Lima Corporate S.P.A., based in Villanova Di San Daniele, is the applicant of record for K252352.

How long did the K252352 review take?

FDA received the submission on Jul 29, 2025 and issued its decision on Jan 22, 2026, 177 days later.

← All decisions in January 2026