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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 / June 2026 / K260802

510(k) cleared

Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Materialise NV · Jun 9, 2026 · K260802

FDA cleared the Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner from Materialise NV on Jun 9, 2026 under K260802, a traditional 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 Mar 11, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Materialise NV has 3 other decisions in the tracker over the last 12 months: K251964 (Mimics Thoracic Planner), K253308 (Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models), K253793 (Materialise TKA Guide System).

Questions & Answers

What did FDA clear under K260802?

K260802 is the FDA 510(k) for Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, submitted by Materialise NV. FDA's decision date was Jun 9, 2026, under product code QHE (Shoulder Arthroplasty Implantation System).

Who makes the Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

Materialise NV, based in Leuven, is the applicant of record for K260802.

How long did the K260802 review take?

FDA received the submission on Mar 11, 2026 and issued its decision on Jun 9, 2026, 90 days later.

← All decisions in June 2026

Sources