FDA Clearance for Bacterin’s OsteoSelect® DBM Putty in Spinal Fusion

Bacterin International Holdings, Inc. has announced it has obtained US FDA 510(k) approval to market OsteoSelect® DBM Putty for use in spinal fusion procedures. OsteoSelect® is a moldable bone graft substitute designed to withstand irrigation while exhibiting osteoinductive properties for improved bone regeneration.

Background

Bacterin describes itself as a leader in the development of revolutionary bone graft material and coatings for medical applications. Its OsteoSelect® DBM Putty is a malleable bone grafting material comprised of demineralized bone matrix allograft combined with a polymer carrier material.

In developing the product, the company claims to have focused on providing solutions to the shortcomings inherent to other commercially available DBM putties. Specifically it claims OsteoSelect’s cohesive nature provides an advantage over the opposition which can readily wash away after placement in wet, surgical environments.

Interestingly we spotted in the company’s press release a striking claim that the putty’s osteoinductive potential is confirmed after sterilization of “every lot” in an animal model. This is claimed to provide surgeons with reassurance that the bone grafting solution is both safe and biologically active. We’re not sure what this need for expensive and to some controversial testing says about the product. One might have expected the production process to have ironed out any variability in likely osteoinduction, but no doubt they know what they’re doing.

As part of the regulatory approval process, Bacterin provided funding to Hospital for Special Surgery in New York to perform a study evaluating the efficacy of OsteoSelect® in a rabbit posterolateral lumbar spine fusion model. Biomechanical, radiographic, and histological analysis indicated that OsteoSelect® showed equivalence to a control of autologous iliac crest bone graft which is widely considered to be the gold standard for spinal fusion.

Company comments 

“We are proud to obtain another indication for use that will provide Bacterin with additional marketing opportunities for the OsteoSelect® DBM Putty product line,” said Gregory Juda, PhD, Bacterin’s Chief Scientific Officer. Dr. Juda continued to say, “In the 3 plus years of OsteoSelect® being on the market, we have seen considerable adoption by the orthopedic community across a variety of surgical specialties. Our post market surveillance supports the efficacy of OsteoSelect® and the results of the preclinical work validate the clinical findings.”

Source: Bacterin International Holdings, Inc., Business Wire