Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™

Mg OSTEOINJECT™, Mg OSTEOREVIVE™, and Mg OSTEOCRETE™ are magnesium-based synthetic bone void fillers designed to fill bone defects in the extremities, pelvis, spine, and intervertebral disc spaces. The devices consist of a powder component and buffered saline mixing solution that form a cohesive, moldable paste when combined intraoperatively, which is then resorbed and replaced with bone during healing.

The subject devices are magnesium-based, moldable, drillable, resorbable, adhesive/cohesive, radiopaque, and osteoconductive bone void fillers provided sterile in sizes from 3 cc to 15 cc. They have identical technological characteristics, materials, physical dimensions, packaging, and sterilization methods to the predicate devices K242372 and K234013.

Testing followed FDA guidance documents for Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (June 2003) and Submission and Review of Sterility Information in Premarket Notification (January 2024). Bacterial endotoxin testing used the Limulus amebocyte lysate (LAL) test per USP <85>, with acceptance criterion ≤20 EU/device.

The subject device is substantially equivalent because it has identical materials, technological characteristics, intended use, and product codes as the primary predicate K242372 and reference device K234013. The only differences are expanded indications to explicitly include pediatric patients >6 years old, which are supported by toxicological risk assessment and animal data demonstrating safe serum magnesium levels, raising no new safety or effectiveness concerns.