FDA Clears Drillable, Injectable Bone Void Fill

The U.S. Food and Drug Administration (FDA) has cleared for commercial sale in the U.S. a magnesium-based injectable bone void filler which has the additional features of being drillable and adhesive.

According to the 510(k) summary indications for use statement, “Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.”

“Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.”

The product, brand names Mg OSTEOINJECT™ is manufactured by Colleyville, Texas-based Bone Solutions, Inc.

The primary predicate device is OSTEOREVIVE™. Mg OSTEOINJECT differs from OSTEOREVIVE in terms of the indications for use because Mg OSTEOINJECT is only indicated for use in the extremities and pelvis.

Bone Solutions, Inc. manufactures the device. Kevin A. Thomas, Ph.D. and Floyd G. Larson, M.S., M.B.A. of PaxMed International, LLC are the representatives/consultants on the 510(k) submission.

OTW spoke with Bone Solutions President and CEO Drew Diaz about Mg OSTEOINJECT. He told OTW, “Mg OSTOINJECT technology has over twice the compression strength (26 MPAs) of cancellous bone with better adhesive qualities than PMMA for short term fixation.”

“Also, MG OSTOINJECT is injectable or moldable and drillable immediately after implantation, with a work time for moldability of up to 45 minutes in the OR. It is 100% resorbed by the body depending on the patient's health, implant mass and site location. MG OSTOINJECT is also the only product on the market which can be reconstituted in order to have zero financial waste.”

Diaz elaborated, “Every known scientific study comparing a magnesium phosphate to a calcium phosphate bone void filler has shown improved/quicker bone remodeling for the magnesium phosphate product. This includes studies utilizing Bone Solutions Inc. technologies as well as independent basic science studies evaluating the properties of magnesium phosphate.”

OTW also spoke with Diaz about the company’s goals for the remainder of the year. “We plan to successfully introduce our new Mg OSTEOINJECT technology into the marketplace. We will also finish our analysis and in vivo studies for our new Mg OSTEORESORB hard magnesium-based resorbable implant technology.”

Diaz continued, “We will also continue to partner with research institutions, healthcare facilities, and commercial partners to grow and improve our current portfolio of magnesium technologies.”