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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 / January 2026 / K253308

510(k) cleared

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models

Materialise NV · Jan 7, 2026 · K253308

FDA cleared the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models from Materialise NV on Jan 7, 2026 under K253308, a special 510(k). The device falls under product code PPT, Cranial Surgical Planning And Instrument Guides, regulated at 21 CFR 882.4310 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 29, 2025. The decision came 100 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Materialise NV has 3 other decisions in the tracker over the last 12 months: K260802 (Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner), K251964 (Mimics Thoracic Planner), K253793 (Materialise TKA Guide System).

Questions & Answers

What did FDA clear under K253308?

K253308 is the FDA 510(k) for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models, submitted by Materialise NV. FDA's decision date was Jan 7, 2026, under product code PPT (Cranial Surgical Planning And Instrument Guides).

Who makes the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models?

Materialise NV, based in Leuven, is the applicant of record for K253308.

How long did the K253308 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jan 7, 2026, 100 days later.

← All decisions in January 2026

Sources