WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / February 2026 / K260104

510(k) cleared

Signature ONE System

Orthosoft Inc. (d/b/a) Zimmer CAS · Feb 4, 2026 · K260104

FDA cleared the Signature ONE System from Orthosoft Inc. (d/b/a) Zimmer CAS on Feb 4, 2026 under K260104, a special 510(k). The device falls under product code QHE, Shoulder Arthroplasty Implantation System, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 13, 2026. The decision came 22 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), K260582 (ROSA® Shoulder System), K251314 (Rosa® Knee System).

Questions & Answers

What did FDA clear under K260104?

K260104 is the FDA 510(k) for Signature ONE System, submitted by Orthosoft Inc. (d/b/a) Zimmer CAS. FDA's decision date was Feb 4, 2026, under product code QHE (Shoulder Arthroplasty Implantation System).

Who makes the Signature ONE System?

Orthosoft Inc. (d/b/a) Zimmer CAS, based in Montreal, is the applicant of record for K260104.

How long did the K260104 review take?

FDA received the submission on Jan 13, 2026 and issued its decision on Feb 4, 2026, 22 days later.

← All decisions in February 2026

Sources