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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 / November 2025 / K251314

510(k) cleared

Rosa® Knee System

Orthosoft Inc. (d/b/a) Zimmer CAS · Nov 13, 2025 · K251314

FDA cleared the Rosa® Knee System from Orthosoft Inc. (d/b/a) Zimmer CAS on Nov 13, 2025 under K251314, 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 Apr 28, 2025. The decision came 199 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Orthosoft Inc. (d/b/a) Zimmer CAS has 3 other decisions in the tracker over the last 12 months: K261510 (Signature ONE System), K260582 (ROSA® Shoulder System), K260104 (Signature ONE System).

Questions & Answers

What did FDA clear under K251314?

K251314 is the FDA 510(k) for Rosa® Knee System, submitted by Orthosoft Inc. (d/b/a) Zimmer CAS. FDA's decision date was Nov 13, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Rosa® Knee System?

Orthosoft Inc. (d/b/a) Zimmer CAS, based in Montreal, is the applicant of record for K251314.

How long did the K251314 review take?

FDA received the submission on Apr 28, 2025 and issued its decision on Nov 13, 2025, 199 days later.

← All decisions in November 2025

Sources