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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 / December 2025 / K252997

510(k) cleared

HyperFlex® Bunion Correction System

Hyperflex Medical · Dec 11, 2025 · K252997

FDA cleared the HyperFlex® Bunion Correction System from Hyperflex Medical on Dec 11, 2025 under K252997, 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 Sep 18, 2025. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Hyperflex Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252997?

K252997 is the FDA 510(k) for HyperFlex® Bunion Correction System, submitted by Hyperflex Medical. FDA's decision date was Dec 11, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the HyperFlex® Bunion Correction System?

Hyperflex Medical, based in Port Huron, MI, is the applicant of record for K252997.

How long did the K252997 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Dec 11, 2025, 84 days later.

← All decisions in December 2025