FDA's Ortho Panel supports down-classification of pedicle screw spinal systems (MassDevice)
The FDA's Orthopedic & Rehabilitations Devices Panel agrees with the FDA's recommendations that pedicle screw spinal systems be officially down-classified to less-stringent regulatory review.
A panel of experts today recommended that FDA lower the regulatory bar for pedicle screw spinal systems, which are intended to treat degenerative disc disease and a limited type of spondylolisthesis, or shifting of vertebra in response to a vertebral stress fracture.
"What we approved for is downgrading to Class II, the use of pedicle screw spine systems as an adjunct to fusion," patient representative Joseph O'Brien of the National Scoliosis Foundation said. "So to me, the warning that's still there should be: there's no evidence of safety and effectiveness in non-fusion."
Pedicle screw spinal systems are one of the remaining pre-amendments class III devices, which means that they were marketed prior to the Medical Device Amendments of 1976. FDA originally classified them as the highest-risk Class III, but to date they've been approved for the the U.S. market via the less-stringent 510(k) premarket...
