BiologicsRegulatory

Bone Solutions Inc. (BSI) receives FDA 510(K) clearance for world’s first and only magnesium-based bone void filler, OsteoCrete™

DALLAS–(BUSINESS WIRE)–Bone Solutions Inc. (BSI) announced today that it has received FDA 510(k) clearance for the first device in its technology pipeline—a proprietary bone void filler, OsteoCrete™, which represents a critical milestone in the Company’s efforts to establish a platform for its patented magnesium-based technology. The Company expects this milestone to trigger its long-term plan to establish its platform as the ‘one-stop bone-, tendon- and ligament-injectable, biodegradable adhesive technology’ for surgeries at hospitals, clinics and other private surgical centers within the orthopedic industry.

“BSI’s OsteoCrete™, now FDA-cleared for long-bone and pelvis applications, establishes a new landscape for expanding breakthroughs in orthobiologics,” said Tom Lally, President of BSI. “Most of today’s leading devices in bone repair or replacement are calcium-based and do not exhibit the combination of features including compressive strength, expandability yielding a major binding quality. OsteoCrete™ is resorbable as it is replaced with bone during the window of healing. OsteoCrete™ is also injectable, osteoconductive, and is non-toxic. Because of the deficiencies of today’s calcium-based bone void fillers and cements, which result in lower surgical success rates, the industry spends millions of dollars annually on new R&D in an attempt to invent better calcium-based products, or better-reinforcing metallic devices such as nails, pins, plates, and screws—some of which are not bioabsorbable,” said Lally. “On the other hand, BSI’s magnesium-based technology along with other ingredients provides significant compressive strength and possesses Ph-neutral qualities that make it ideal as a delivery system for possible future applications.”

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

Related Articles

Back to top button