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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 / October 2025 / K250394

510(k) cleared

Fine TTO

Bodycad Laboratories, Inc. · Oct 21, 2025 · K250394

FDA cleared the Fine TTO from Bodycad Laboratories, Inc. on Oct 21, 2025 under K250394, a traditional 510(k). The device falls under product code PBF, Orthopaedic Surgical Planning And Instrument Guides, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 12, 2025. The decision came 251 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bodycad Laboratories, Inc. has one other decision in the tracker over the last 12 months: K253300 (Fine Osteotomy).

Questions & Answers

What did FDA clear under K250394?

K250394 is the FDA 510(k) for Fine TTO, submitted by Bodycad Laboratories, Inc.. FDA's decision date was Oct 21, 2025, under product code PBF (Orthopaedic Surgical Planning And Instrument Guides).

Who makes the Fine TTO?

Bodycad Laboratories, Inc., based in Quebec, is the applicant of record for K250394.

How long did the K250394 review take?

FDA received the submission on Feb 12, 2025 and issued its decision on Oct 21, 2025, 251 days later.

← All decisions in October 2025

Sources