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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 / November 2025 / K252661

510(k) cleared

SternaFuse Ti Fixation System

Fusion Innovations, LLC · Nov 19, 2025 · K252661

FDA cleared the SternaFuse Ti Fixation System from Fusion Innovations, LLC on Nov 19, 2025 under K252661, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 22, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Fusion Innovations, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252661?

K252661 is the FDA 510(k) for SternaFuse Ti Fixation System, submitted by Fusion Innovations, LLC. FDA's decision date was Nov 19, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the SternaFuse Ti Fixation System?

Fusion Innovations, LLC, based in Maitland, FL, is the applicant of record for K252661.

How long did the K252661 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Nov 19, 2025, 89 days later.

← All decisions in November 2025