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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 / K253202

510(k) cleared

Hoffmann LRF System

Stryker GmbH · Dec 19, 2025 · K253202

FDA cleared the Hoffmann LRF System from Stryker GmbH on Dec 19, 2025 under K253202, a traditional 510(k). The device falls under product code KTT, Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 26, 2025. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

Stryker GmbH has 2 other decisions in the tracker over the last 12 months: K261481 (Pangea Femur Reconstruction System), K253640 (T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System).

Questions & Answers

What did FDA clear under K253202?

K253202 is the FDA 510(k) for Hoffmann LRF System, submitted by Stryker GmbH. FDA's decision date was Dec 19, 2025, under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Who makes the Hoffmann LRF System?

Stryker GmbH, based in Selzach, is the applicant of record for K253202.

How long did the K253202 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Dec 19, 2025, 84 days later.

← All decisions in December 2025

Sources