Panel highlights lack of support on safety, efficacy of spinal sphere devices for fusion (Healio)
In a meeting about the FDA's recommendation to categorize spinal sphere devices for use in fusion procedures as class III, the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee noted the risks of the product as identified by the FDA are adequate with the addition of a significant or unacceptable risk of revision.
The panel also held there are no reasonable assurances of safety or efficacy of these devices for this indication and agreed with the FDA's assessments that the risk of injury is unreasonable given the lack of probable benefit. They found that insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of the safety and effectiveness of spinal sphere devices.
The devices, intended to provide stability and aid in intervertebral body fusion, are placed between the vertebral bodies and into the disc space from L3 to S1.
During the panel meeting, the FDA presented its literature review of five articles about spinal sphere devices published up to Aug. 15. One of the articles was a...
