Orthobiologics technology firm Bone Solutions (BSI) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its magnesium-based bone void filler called Mg OSTEOREVIVE.

The company has developed the new magnesium-based injectable and moldable bone void filler for use in posterolateral spine fusion procedures.

According to the company, the flowable product promotes bone repair and regeneration within insufficiency and micro fractures.

Magnesium, a crucial component for bone health, consists of high specific strength and a modulus of elasticity that closely resembles human bone, said the company.

BSI also stated that around 60% of magnesium in the body resides in the bones and supports in the development of bone, as well as plays a crucial role in the absorption and regulation of calcium.

Due to these characteristics, Mg OSTEOREVIVE has the ability to safely assimilate back into the body during the healing process as it is replaced with bone.

BSI president and CEO Drew Diaz said: “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.”

At present, BSI is supplying the new magnesium-based bone void filler to facilities and surgical centres across the world for immediate clinical use.

BSI offers biologically safe and fully resorbable magnesium-based orthopaedic implant solutions for use in complex procedures.

The company is engaged in the development of several new orthopedic technologies within its FDA-cleared magnesium-based platform.