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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 / K254087

510(k) cleared

MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System

Synthes (USA) Products, LLC · Jun 11, 2026 · K254087

FDA cleared the MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System from Synthes (USA) Products, LLC on Jun 11, 2026 under K254087, 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 Dec 18, 2025. The decision came 175 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Synthes (USA) Products, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254087?

K254087 is the FDA 510(k) for MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System, submitted by Synthes (USA) Products, LLC. FDA's decision date was Jun 11, 2026, under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Who makes the MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System?

Synthes (USA) Products, LLC, based in West Chester, PA, is the applicant of record for K254087.

How long did the K254087 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Jun 11, 2026, 175 days later.

← All decisions in June 2026