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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 / K243078

510(k) cleared

HexaPLUS S OneDrill Implant System

Osseofuse International, Inc. · Oct 10, 2025 · K243078

FDA cleared the HexaPLUS S OneDrill Implant System from Osseofuse International, Inc. on Oct 10, 2025 under K243078, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 30, 2024. The decision came 375 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 Osseofuse International, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243078?

K243078 is the FDA 510(k) for HexaPLUS S OneDrill Implant System, submitted by Osseofuse International, Inc.. FDA's decision date was Oct 10, 2025, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the HexaPLUS S OneDrill Implant System?

Osseofuse International, Inc., based in Las Vegas, NV, is the applicant of record for K243078.

How long did the K243078 review take?

FDA received the submission on Sep 30, 2024 and issued its decision on Oct 10, 2025, 375 days later.

← All decisions in October 2025