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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 / May 2026 / K260582

510(k) cleared

ROSA® Shoulder System

Orthosoft Inc. (d/b/a) Zimmer CAS · May 21, 2026 · K260582

FDA cleared the ROSA® Shoulder System from Orthosoft Inc. (d/b/a) Zimmer CAS on May 21, 2026 under K260582, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 20, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Orthosoft Inc. (d/b/a) Zimmer CAS has 3 other decisions in the tracker over the last 12 months: K261510 (Signature ONE System), K260104 (Signature ONE System), K251314 (Rosa® Knee System).

Questions & Answers

What did FDA clear under K260582?

K260582 is the FDA 510(k) for ROSA® Shoulder System, submitted by Orthosoft Inc. (d/b/a) Zimmer CAS. FDA's decision date was May 21, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the ROSA® Shoulder System?

Orthosoft Inc. (d/b/a) Zimmer CAS, based in Montreal, is the applicant of record for K260582.

How long did the K260582 review take?

FDA received the submission on Feb 20, 2026 and issued its decision on May 21, 2026, 90 days later.

← All decisions in May 2026

Sources