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FDA Grants 510(K) Clearance To Bone Solutions’ OsteoCrete Bone Void Filler

Bone Solutions Inc. announced that it has received FDA 510(k) clearance for OsteoCrete bone void filler. This represents a critical milestone in the company’s efforts to establish a platform for its patented magnesium-based technology. BSI 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 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 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.”

This FDA-cleared device makes use of a similar material composite noted in the patent that the FDA cleared for long-bone and pelvis applications. OF NOTE: The BSI technology began as a breakthrough rapid-set cement product with major binder qualities for patching highways that would stay tough in bitterly cold temperatures.

“Our patented magnesium-based technology is well-positioned as a platform for new approaches and new devices to be introduced into orthopedic surgery repair,” added Dr. Tony Copp, BSI’s EVP/COO. “Our strategy has been to first seek FDA clearance of OsteoCrete as a bone void filler by applying existing FDA guidance protocols for bone void fillers. In the future, we intend to seek further clearance of OsteoCrete for applications in cranial surgery, maxillofacial surgery, non-load-bearing spine applications, and as a bone anchor and bone cement. In the meantime, we intend to commence sales efforts for OsteoCrete as a bone void filler for human markets in long-bone and pelvis applications,” said Dr. Copp.

“The fact is that we have had discussions with companies that comprise more than 90 percent of the orthopedic industry worldwide to explore the opportunity for strategic alliances. Initial target vertical markets include all extremities, maxillofacial/cranial, shoulder- and knee-related surgical procedures, and initially non-load-bearing spinal applications and musculoskeletal allograft uses. These will require future FDA and other governmental regulatory certification for global sales,” said Tom Lally.

OsteoCrete Bone Void Filler is a biocompatible magnesium-based bone void filler that is both injectable and moldable. It is indicated for bony voids or defects that are not intrinsic to the stability of the bony structure. OsteoCrete is intended to be placed or injected into bony voids or gaps of the skeletal system (the long bone and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. OsteoCrete provides a bone void filler that resorbs and is replaced with bone during the healing process.