From navigation tools to surgery systems, here are eight orthopedic and spine systems, devices and implants that have received FDA clearance, as reported by Becker’s since April 27:
- Mighty Oak Medical’s Acorn 3D pre-surgical correction planning software earned FDA clearance.
- SurGenTec earned FDA 510(k) clearance for its ION-L lumbar facet fixation system
- Medtech company OrthoAlign received FDA 510(k) clearance for its Lantern ASC system.
- SurGenTec’s ION-C earned FDA 510(k) clearance for ION-C navigation instruments with the ION-C posterior cervical facet fixation implant.
- Zimmer Biomet secured 510(k) clearance from the FDA for an advanced version of its ROSA Shoulder System.
- FX Shoulder Solutions secured FDA 510(k) clearance for its next-generation stemless shoulder arthroplasty implants.
- Avatar Medical earned FDA 510(k) clearance for Avatar Medical Vision, a software that provides instant 3D medical image processing, review and surgical planning for orthopedics and neurosurgery.
- Pixee Medical received FDA 510(k) clearance for its augmented reality platform for total knee arthroplasty.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
