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Mg OSTEOINJECT™ +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K234013

by Bone Solutions, Inc.

Identifiers

510(k) Number
K234013 FDA 510(k)
FDA Product Code
MQV FDA 510(k)
Models / Variants
Mg OSTEOINJECT™ FDA 510(k)
Mg OSTEOREVIVE™ FDA 510(k)
Mg OSTEOCRETE™ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3045 FDA 510(k)
Regulation Number
888.3045 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Mg Osteoinject; Mg Osteorevive; Mg Osteocrete are resorbable calcium salt bone void fillers classified under 21 CFR 888.3045. These devices consist of a magnesium-based, synthetic blend designed to fill bone defects and gradually remodel into natural bone through a process called creeping substitution. The formulations are optimized for use in trauma, extremity, revision, and sports medicine procedures, providing structural support during the healing process.

The devices are supplied as pre-measured, fast-setting materials intended for single-use in surgical settings. They are regulated under FDA 510(k) clearance (K234013) with a traditional review pathway, classified under the Orthopedic advisory committee. No information regarding sterility, MRI safety, or reusable status is provided in the available data. Storage conditions and additional regulatory details are not specified beyond the FDA clearance.

Frequently asked questions

What types of surgical procedures are these magnesium-based bone void fillers primarily intended for?

These devices—Mg Osteoinject™, Mg Osteorevive™, and Mg Osteocrete™—are designed for filling bone defects in trauma, extremity, revision, and sports medicine surgeries. Their magnesium-based, synthetic blend provides structural support during the healing process, gradually remodeling into natural bone through a process called creeping substitution.

Are these bone void fillers reusable, or are they meant for single-use only?

The available data specifies that these devices are supplied as pre-measured, fast-setting materials intended for single-use in surgical settings. There is no indication in the provided information that they are reusable.

How are these magnesium-based bone void fillers regulated in the U.S., and what committee oversees their review?

These devices are regulated under the FDA 510(k) clearance pathway with the classification 21 CFR 888.3045 (Orthopedic bone void fillers). Their review falls under the Orthopedic Advisory Committee (OR) and follows a traditional review pathway, with clearance granted under K234013.

What form do these bone void fillers come in, and how are they prepared for use?

They are supplied as pre-measured, fast-setting materials, meaning they are ready for immediate use in surgical settings without requiring additional preparation. The exact packaging format (e.g., syringes, kits) isn’t detailed, but the emphasis is on convenience for in-operative use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (K251522) — FDA 510 (k ..., Mg OSTEOINJECT | Bone Solutions New, Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (K234013) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bone Solutions, Inc.

Sources (1)

  • FDA 510(k) K234013 24 fields · synced Sep 20, 2026