WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253793

510(k) cleared

Materialise TKA Guide System

Materialise NV · Jan 6, 2026 · K253793

FDA cleared the Materialise TKA Guide System from Materialise NV on Jan 6, 2026 under K253793, a special 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 28, 2025. The decision came 39 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: K260802 (Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner), K251964 (Mimics Thoracic Planner), K253308 (Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models).

Questions & Answers

What did FDA clear under K253793?

K253793 is the FDA 510(k) for Materialise TKA Guide System, submitted by Materialise NV. FDA's decision date was Jan 6, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the Materialise TKA Guide System?

Materialise NV, based in Leuven, is the applicant of record for K253793.

How long did the K253793 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Jan 6, 2026, 39 days later.

← All decisions in January 2026

Sources