Here are spine spine and orthobiologics technologies that have received FDA approval so far this year, as reported by Becker’s.
Note: This list is not exhaustive.
- Alafair Biosciences earned FDA 510(k) clearance for the VersaCoat tendon protector and VersaCoat nerve protector.
- SurGenTec earned additional FDA clearance for its OsteoFlo HydroFiber.
- TBYR Health earned FDA clearance for its B3 gel system, a bioresorbable gel barrier that protects healing tissue planes and preserves mobility following tendon, ligament and skeletal muscle surgeries.
- CGBIO, a South Korea-based company, earned the FDA’s investigational device exemption approval for its Novosis putty for spinal fusions.
- Miach Orthopaedics’ BEAR implant is now available to treat children and adolescents with anterior cruciate ligament tears after the FDA expanded its clearance.
- SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a stand-alone equivalent to autografts in spine surgeries.
- Ventris Medical earned FDA 510(k) clearance for its Backpack bone graft containment system.
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