FDA Grants Approval to OsteoSelect Putty for Spinal Fusions

Bacterin International Holdings received FDA 510(k) approval for its OsteoSelect DBM Putty to be used in spinal fusion procedures. The moldable bone graft substitute has osteoinductive properties for bone regeneration and will not wash away after placement in wet surgical environments, according to the release.

The Hospital for Special Surgery in New York conducted a study on the efficacy of OsteoSelect in a rabbit posterolateral lumbar spine fusion model. Bacterin paid for the study. Results showed the material's control equal to that of autologous iliac crest bone grafts.

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