FDA classifies spinal spheres into class III assignment
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Key takeaways:
- This final rule was determined based on lack of available evidence to determine reasonable assurance of safety and effectiveness.
- Spinal spheres also present an unreasonable risk of illness or injury, FDA said.
The FDA issued a final rule to classify spinal spheres for use in intervertebral fusion procedures into class III assignment and to require the filing of premarket approval applications for these products.
The final rule is effective on May 1. The FDA determined this final rule based on lack of available evidence to determine that general and special controls are sufficient to provide reasonable assurance of safety and effectiveness of these devices. The FDA also noted these devices present an unreasonable risk of illness or injury, including reoperation, pain and loss of function, infection, adverse tissue reaction, soft tissue injury, vertebral endplate injury, pseudarthrosis, implant migration and/or instability, and implant breakage during insertion.
“Anyone who wishes to market spinal spheres for use of intervertebral fusion procedures will need to submit a [premarket approval] application prior to the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective,” according to the FDA.
References:
- Effective date of requirement for premarket approval applications for spinal spheres for use in intervertebral fusion procedures. https://www.federalregister.gov/documents/2023/03/30/2023-06565/effective-date-of-requirement-for-premarket-approval-applications-for-spinal-spheres-for-use-in?utm_medium=email&utm_source=govdelivery. Published March 30, 2023. Accessed April 11, 2023.
- Medical devices; orthopedic devices; classification of spinal spheres for use in intervertebral fusion procedures. https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion. Published March 30, 2023. Accessed April 11, 2023.
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