Headquartered in Montana and spun out of Montana State University’s Center for Biofilm Engineering, Xtant Medical develops and manufactures regenerative biologics, human tissue grafts, and spinal fixation systems for orthopedic and neurological surgery. The company operates Montana’s largest tissue bank and vertically integrates donor recovery, patented processing, and distribution, using technologies such as BacteRinse™ to preserve native growth factors. Its work is rooted in honoring tissue donors while helping surgeons support bone healing and spinal fusion.
AATB Accreditation — Bacterin Biologics
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ISO 13485
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CTO Canada
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FDA Biologics
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FDA Hardware
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Health Canada Device — OsteoSelect DBM Putty
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Health Canada Device — Silex
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California State License
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Delaware State License
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Florida State License
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Illinois State License
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Louisiana State License
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Maryland State License
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New York State License
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Xtant MedicalBorn from Montana State University’s Center for Biofilm Engineering, Xtant Medical is a Montana-headquartered tissue bank and medical-device manufacturer developing orthobiologics and spinal fixation systems. Its vertically integrated operations span donor recovery, patented tissue processing and distribution, with technologies such as BacteRinse™ used to preserve growth factors while honoring each donation. Xtant says it has 25 years of clinical success and maintains AATB accreditation alongside ISO 13485 and MDSAP certification.MIAMISBURG, OH
OrthofixFounded in 1980, Orthofix is a Lewisville, Texas-based medical technology company that develops devices and biologic solutions for spine care and limb reconstruction. Its work spans reconstructive and regenerative treatment, including bone-growth therapies and the 7D FLASH Navigation System, with products used to help patients regain mobility in more than 60 countries. Orthofix also develops biologics through its in-house tissue bank in Irvine, California, and collaborations with MTF Biologics.WAYNE, PA
Synergy Biomedical, LLCSynergy Biomedical, a privately held Wayne, Pennsylvania medical-device company, develops biomaterial bone-graft products for orthopedic and spinal surgery. Its BioSphere® technology uses spherical 45S5 bioactive-glass particles in a controlled bimodal size range, an approach the company developed to improve bone healing and distinguish its grafts from conventional irregular-particle materials. Synergy Biomedical is certified to ISO 13485 and operates a quality system aligned with FDA requirements.WAYNE, PA
Omnia MedicalFounded by engineers and medical-device professionals, Morgantown, West Virginia-based Omnia Medical develops orthopedic implants for spine and interventional pain care. Its work is especially focused on sacroiliac-joint stabilization, including the PsiFGuard system, which the company describes as FDA-cleared real-time guidance technology for SI-joint detection. Omnia also develops spinal fusion and biologic solutions through surgeon collaboration, with a mission centered on safe, reproducible instrumentation and shorter operative times.MORGANTOWN, WV