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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 / April 2026 / K252699

510(k) cleared

CoAptix S System

University of Utah, Department of Orthopaedics · Apr 10, 2026 · K252699

FDA cleared the CoAptix S System from University of Utah, Department of Orthopaedics on Apr 10, 2026 under K252699, a traditional 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 27, 2025. The decision came 226 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 University of Utah, Department of Orthopaedics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252699?

K252699 is the FDA 510(k) for CoAptix S System, submitted by University of Utah, Department of Orthopaedics. FDA's decision date was Apr 10, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the CoAptix S System?

University of Utah, Department of Orthopaedics, based in Salt Lake City, UT, is the applicant of record for K252699.

How long did the K252699 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on Apr 10, 2026, 226 days later.

← All decisions in April 2026