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 notification process.
FDA asked its Orthopedic & Rehabilitation Devices Panel to weigh in on whether an premarket approval for pedicle screws is necessary, or if they can be down-classified to the less burdensome Class II for use as an adjunct to fusion and for a limited form of spondylolisthesis, as the agency itself suggested in background materials released ahead of the meeting.
FDA based its down-classification suggestion on data provided by some 20 manufacturers in response to a 2009 FDA request for information that safety and effectiveness of pedicle screws can be assured through non-clinical testing, material composition, sterilization validation and labeling.
Today’s panel agreed with FDA’s assessment that pedicle screws can be down-classified to Class II and said that available evidence for pedicle screws already on the market shows reasonable assurance of safety and effectiveness, proposing that special controls are sufficient to prove this for any new devices in this group.
The panel went a step further and recommended that dynamic stabilization systems (DSS) – a subtype of pedicle screw systems, which have different design features from traditional, rigid pedicle screw systems and which allow bending or rotation while still facilitating fusion – could also be down-classified into Class II with special controls, an FDA spokeswoman toldMassDevice.com after the meeting. This recommendation came despite FDA’s acknowledgment in background materials that there is insufficient safety and effectiveness information for DSS.
The FDA will next consider the evidence and input from panel members, who essentially backed up all of FDA’s recommendations, the FDA spokeswoman said. The agency will then publish a proposed order, which will be open for public comments. After consideration of all additional comments, the agency will issue a final order to classify pedicle screws into a risk category.
What down-classification means for pedicle screw manufacturers
If FDA follows the panel’s recommendation and down-classifies pedicle screws to Class II, these devices would continue to be subject to the premarket notification 510(k) requirements and any special controls specified in the final classification order.
510(k) holders are not subject to as stringent postmarket oversight as PMA holders, FDA noted. If the regulatory bar is lowered for pedicle screws, companies with existing legally marketed pedicle screws would need to adhere to the newly defined special controls, and would have to ensure that their existing products meet all specified requirements.
New pedicle screws and changes to existing devices that require a new submission to FDA would require a 510(k), demonstration that the special controls have been met, and a substantial equivalence determination.
A 510(k) submission can leverage existing information on predicate devices, including applicable clinical data, to support marketing clearance, FDA noted. For devices subject to 510(k), the premarket submission only has to prove that the device has indications and technological characteristics similar to existing legally marketed predicate devices and meet any required special controls.
Pedicle screws are posterior spinal screw and rod systems designed as an adjunct to fusion for the treatment of degenerative disc disease, trauma, deformity, failed previous fusion, tumor, infection, and inflammatory disorders in the thoracolumbar spine, FDA noted in background materials released ahead of the meeting.
The devices are also indicated for treating spondylolisthesis other than severe spondylolisthesis (grades 3 and 4) at L5-S1, or degenerative spondylolisthesis with evidence of neurologic impairment, according to the agency.