WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K251522

510(k) cleared

Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE

Bone Solutions, Inc. · Oct 13, 2025 · K251522

FDA cleared the Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE from Bone Solutions, Inc. on Oct 13, 2025 under K251522, a traditional 510(k). The device falls under product code MQV, Filler, Bone Void, Calcium Compound, regulated at 21 CFR 888.3045 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 16, 2025. The decision came 150 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 Bone Solutions, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251522?

K251522 is the FDA 510(k) for Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE, submitted by Bone Solutions, Inc.. FDA's decision date was Oct 13, 2025, under product code MQV (Filler, Bone Void, Calcium Compound).

Who makes the Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE?

Bone Solutions, Inc., based in Colleyville, TX, is the applicant of record for K251522.

How long did the K251522 review take?

FDA received the submission on May 16, 2025 and issued its decision on Oct 13, 2025, 150 days later.

← All decisions in October 2025