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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 / December 2025 / K250711

510(k) cleared

VSP Orthopedics System

3D Systems, Inc. · Dec 5, 2025 · K250711

FDA cleared the VSP Orthopedics System from 3D Systems, Inc. on Dec 5, 2025 under K250711, 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 Mar 10, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

3D Systems, Inc. has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K250711?

K250711 is the FDA 510(k) for VSP Orthopedics System, submitted by 3D Systems, Inc.. FDA's decision date was Dec 5, 2025, under product code PBF (Orthopaedic Surgical Planning And Instrument Guides).

Who makes the VSP Orthopedics System?

3D Systems, Inc., based in Littleton, CO, is the applicant of record for K250711.

How long did the K250711 review take?

FDA received the submission on Mar 10, 2025 and issued its decision on Dec 5, 2025, 270 days later.

← All decisions in December 2025