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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 / K252254

510(k) cleared

Osteotomy Wedge System

Sinaptic Surgical · Oct 17, 2025 · K252254

FDA cleared the Osteotomy Wedge System from Sinaptic Surgical on Oct 17, 2025 under K252254, a traditional 510(k). The device falls under product code PLF, Bone Wedge, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 21, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Sinaptic Surgical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252254?

K252254 is the FDA 510(k) for Osteotomy Wedge System, submitted by Sinaptic Surgical. FDA's decision date was Oct 17, 2025, under product code PLF (Bone Wedge).

Who makes the Osteotomy Wedge System?

Sinaptic Surgical, based in Slat Lake City, UT, is the applicant of record for K252254.

How long did the K252254 review take?

FDA received the submission on Jul 21, 2025 and issued its decision on Oct 17, 2025, 88 days later.

← All decisions in October 2025