Xtant Medical Holdings Inc., a company in Belgrade, Montana, whose subsidiary, Bacterin International, Inc. makes regenerative medicine products has received FDA 510(k) clearance for its OsteoSelect PLUS. The product is a demineralized bone matrix, comprised of OsteoSelect Putty but with the demineralized cortical chips.
FDA Clears Xtant Medical’s Bone Putty
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Adding cortical chips to OsteoSelect putty eliminates the need to mix bone chips and demineralized bone matrix (DBM) putty intra-operatively, saving time and reducing graft variability.
“We are very pleased with the FDA’s decision to approve [sic] OsteoSelect PLUS for marketing and distribution, ” said Gregory Juda, Bacterin’s chief scientific officer. “We developed this next generation bone graft material in response to surgeon demand using design input from surgeon customers…. This is the first 510(k) approval [sic] for Bacterin International since becoming a subsidiary of Xtant Medical.”
Xtant Medical Holdings develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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