Bone Solutions Gains FDA Clearance for Mg OSTEOREVIVE Spine Magnesium-Based Bone Void Filler

By Julie A. Vetalice

Bone Solutions Gains FDA Clearance for Mg OSTEOREVIVE Spine Magnesium-Based Bone Void Filler

Bone Solutions received FDA 510(k) clearance to market Mg OSTEOREVIVE, a magnesium-based injectable and moldable bone void filler indicated for posterolateral spine fusion procedures.

The efficacy of magnesium was a key component of BSI’s approach to developing the Mg OSTEOREVIVE technology. A critical component for bone health and development, magnesium contains high specific strength and a modulus of elasticity that closely resembles human bone. Approximately 60% of magnesium in the body resides in the bones, contributing to the structural development of bone and playing a key role in the absorption and regulation of calcium.

Because of these characteristics, Mg OSTEOREVIVE is able to safely assimilate back into the body during the healing process as it is replaced with bone.

Mg OSTEOREVIVE is currently being distributed to facilities and surgical centers nationwide for immediate clinical use. This follows the launch of the company's Mg OSTEOINJECT, reportedly the first injectable bone void filler in the U.S. to incorporate magnesium, last month.

“This FDA clearance is a key step in the development of Bone Solutions,” stated BSI president and CEO, Drew Diaz. “Introducing Mg OSTEOREVIVE to the spine market is a further demonstration of our commitment to delivering superior magnesium-based orthopedic solutions to address market needs. Mg OSTEOREVIVE is an important contribution as it is the only magnesium-based bone repair product for spine fusion procedures that combines compression strength, handling qualities, and resorption characteristics for optimal bone remodeling and healing.”

Source: Bone Solutions Inc.

Product Labels: Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory