FDA issued a final ruling to classify spinal balls for intervertebral Fusion procedures as class III assignment. This rule also required the submission of premarket approval applications.
Effective May 1, the final rule will become effective. FDA based this final rule on a lack of evidence to establish that both general and specific controls provide sufficient assurance of safety and effectiveness for these devices. These devices pose an unreasonable risk for illness or injury. This includes reoperations, pain, loss of function, and infection.