From biologics to robots, here are seven spine products earning FDA nods since March 18.
1. Tenon Medical earned FDA 510(k) clearance to use its Catamaran sacroiliac joint system for augmenting thoracolumbar fusion. With the new indication Catamaran can be used as a standalone treatment or to augment spinal fusion.
2. Aurora Spine earned FDA 510(k) clearance for its Aero facet fusion system. Aero is a minimally invasive system for facet joint-related pain or instability in levels C2 to S1.
3. Medivis has earned FDA clearance for its spine navigation platform, ahead of its commercial launch in the U.S. The platform can be used for both orthopedic and neurosurgery, utilizing augmented reality and artificial intelligence to provide surgeons holographic navigation across open and minimally invasive spine procedures.
4. Ventris Medical earned FDA clearance to use its Backpack bone graft in intervertebral disc space.
5. LEM Surgical’s Dynamis robot for spine surgery earned FDA 510(k) clearance. The robot is the first multi-arm system for hard tissue surgery. Two arms are for surgical guidance, and one is for optical navigation. It supports a wide range of surgical instruments.
6. CGBIO, a South Korea-based company, earned the FDA’s investigational device exemption approval for its Novosis putty for spinal fusions.The bone graft incorporates rhBMP-2 and is designed to enhance high-density bone formation and minimize ectopic bone growth.
7. Eminent Spine earned FDA 510(k) clearance for its 3D-printed titanium pedicle screw system. The milestone makes it the first and only system of its kind to earn FDA clearance, and it is made from 100% 3D-printed titanium.
