Scope: Develop software and build multi-axis fatigue cycle test systems for spinal disk replacement device.
Challenge: Quick-turn molding used to evaluate material validity at a low cost.
Outcome: Client achieved significant savings by changing material selection from PEEK to titanium early in the development process. Spinal Kinetics was acquired by Orthofix in 2018. More than 50,000 M6-C and M6-L artificial disks were implanted by March, 2018.
FDA approved PMA in 2019