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Ortho panel recommends FDA transitions pedicle screw systems to class II
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The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee recommended today that pedicle screw systems for the thoracolumbosacral spine be reclassified as 510(k) class II devices.
The FDA sought the panel’s input on reclassification of the devices to premarket notification class II or class I or keeping them as premarket approval (PMA) class III devices.
The screws that panel members deliberated over are used in the thoracic, lumbar and sacral spine as adjuncts to fusion for degenerative disc disease (DDD) and non-severe spondylolisthesis at L5-S1 (grades 3 or 4) and spondylolisthesis coupled with proven signs of neurologic impairment.
“We, as a panel, determined that they were indeed safe and effective, although there was significant interest in pursuing further clinical data,” John D. Kelly IV, MD, panel chair for the Orthopaedic and Rehabilitation Devices Panel, told Orthopedics Today.
John D. Kelly IV
Systems used for two indications
“With the special controls that a Class II device would require, we thought [the devices were] safe and effective for public usage. The biggest reason was the indications for this device that had already been approved for class II were far more risky and dangerous than the indications presented today, which were for DDD and low-grade spondylolisthesis. If the indications for fusion are present for those two conditions, we thought there were sufficient data to suggest that pedicle screw usage would enhance and ensure more predictable fusion,” Kelly said after the meeting.
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Had the panel recommended the systems remain class III, this would have required more stringent post-market oversight according to the Section 515 Initiative or Section 515(i) of the Federal Food, Drug, and Cosmetic Act, which requires device manufacturers to submit PMA applications to prove their products are safe and effective. Such proof, according to the FDA, may include clinical trials, minor device modifications or labeling changes, as well as detailed manufacturing changes and an annual report. However, based on background materials at the FDA website, a class II device under 510(k), for example, does not require a report be sent to the FDA for minor labeling changes.
The pedicle screw spinal systems considered by the panel today use longitudinal rods, spinal anchors such as screws, hooks or wires, and optional transverse connectors to stabilize single or multiple spinal motion segments from the upper thoracic spine to the sacrum for spinal fusion. They are made of various materials including stainless steel, stainless steel alloys and unalloyed titanium.
Next steps
In the future, the FDA is expected to issue a proposed order to reclassify these pedicle screws to class II, hold a public comment period, and issue a final order to classify the device, an FDA spokeswoman said.
If the FDA decides to take the panel’s recommendation to reclassify these devices to 510(k) class II, this would allow manufacturers introducing new products of this kind to use a similar predicate device now on the market in the United States to prove their product’s safety and effectiveness.
Previously, pedicle screw systems were in the class III category, but regulated through 510(k) because products on the market prior to the 1970s were all regulated through the 510(k) program. The FDA developed the 515(i) to gradually grandfather devices from the 510(k) program to other classes by reclassifying them as class I or class II or requiring PMA applications through reclassification to Class III. As of 2009, there were still 26 medical device classification regulations that awaited transition to final classification, including pedicle screw spinal systems.
Reference:
www.fda.gov/AdvisoryCommittees/Calendar/ucm346715.htm
Perspective
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David A. Wong, MD, MSc, FRCS(C)
We now have more than a 25-year history of pedicle screw use so compared to the initial reviews that went on in the 1980s where there was not sufficient experience to really establish the safety and efficacy. I think at this stage in the game, they have been in use for many years, tried and true, and with reasonable safety profile and I certainly think the down classification was long overdue. That is the proper decision.
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