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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 / K252418

510(k) cleared

Catalyst F1x Shoulder System

Catalyst Orthoscience, Inc. · Nov 6, 2025 · K252418

FDA cleared the Catalyst F1x Shoulder System from Catalyst Orthoscience, Inc. on Nov 6, 2025 under K252418, a traditional 510(k). The device falls under product code KWS, Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 1, 2025. The decision came 97 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 Catalyst Orthoscience, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252418?

K252418 is the FDA 510(k) for Catalyst F1x Shoulder System, submitted by Catalyst Orthoscience, Inc.. FDA's decision date was Nov 6, 2025, under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented).

Who makes the Catalyst F1x Shoulder System?

Catalyst Orthoscience, Inc., based in Naples, FL, is the applicant of record for K252418.

How long did the K252418 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Nov 6, 2025, 97 days later.

← All decisions in November 2025