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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 / October 2025 / K251643

510(k) cleared

Synchfix EVT

Wright Medical Technology, Inc. (Stryker Corporation) · Oct 29, 2025 · K251643

FDA cleared the Synchfix EVT from Wright Medical Technology, Inc. (Stryker Corporation) on Oct 29, 2025 under K251643, a traditional 510(k). The device falls under product code HTN, Washer, Bolt Nut, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 29, 2025. The decision came 153 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Wright Medical Technology, Inc. (Stryker Corporation) has 2 other decisions in the tracker over the last 12 months: K253159 (Prophecy Incompass Surgical Planning System), K252085 (Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)).

Questions & Answers

What did FDA clear under K251643?

K251643 is the FDA 510(k) for Synchfix EVT, submitted by Wright Medical Technology, Inc. (Stryker Corporation). FDA's decision date was Oct 29, 2025, under product code HTN (Washer, Bolt Nut).

Who makes the Synchfix EVT?

Wright Medical Technology, Inc. (Stryker Corporation), based in Memphis, TN, is the applicant of record for K251643.

How long did the K251643 review take?

FDA received the submission on May 29, 2025 and issued its decision on Oct 29, 2025, 153 days later.

← All decisions in October 2025

Sources