FDA panel deliberates moving two pre-amendment devices to class 2
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The Orthopaedic and Rehabilitation Devices Panel of the FDA Medical Devices Advisory Committee, which met virtually today, recommended against moving cemented semi-constrained toe joint prostheses to class 2.
In addition to coming to that conclusion, the panel also determined that class 2, which includes general and special controls, was appropriate for intracompartmental pressure monitoring devices. However, some panel members requested the FDA consider some modifications to labeling and ways to account for user error with the devices in its final decision concerning classification of intracompartmental pressure monitors.
The panel members’ conclusions came on the second day of a 2-day meeting.
Both devices are currently pre-amendment devices and are unclassified, as such, because some products in those categories entered the marketplace before May 1976 when the FDA Medical Device Amendments of 1976 were enacted.
Semi-constrained metatarsophalangeal joint prostheses — product code LZJ — are generally indicated for reconstruction of painful and/or severely disabled great toe joints, according to the FDA executive summary document. “The device is intended for cemented use only. Indications include painful degenerative metatarsophalangeal joint change; hallux rigidus stage 3 and 4 (including rheumatoid and osteoarthritis causes of hallux rigidus); and revisions after moderate proximal phalanx resection,” according to the summary.
More rigorous controls needed
According to comments from panel members, they based their refusal to place cemented semi-constrained toe prostheses in class 2 on several factors. These included that few studies in the literature discuss the benefits of the procedure and there are considerable adverse events — including significant bone loss and possible amputations — associated with the implants that may lead to reduced quality of life and function in patients.
One panelist echoed the importance of doing no harm in his comments, while others indicated the more rigorous class 3 designation might be more appropriate for these implants.
Panel member Glenn B. Pfeffer, MD, an orthopedic foot and ankle surgeon and director of the Foot and Ankle Center at Cedars-Sinai Medical Center in Los Angeles, was against class 2 designation of these prostheses and cited a level 1 study that he said speaks against the implants.
Pfeffer, who’s been in practice 32 years, said the way the FDA presentations unfolded gave him the impression the FDA would say the cemented semi-constrained toe prostheses should be taken off the market. “Forget about class 2,” he said.
“If you just look at your papers, poor function, problems, used off label, patient pain and suffering, difficult salvage, equals no devices. That’s actually what my opinion is, that these devices should not be allowed ever again to be put into a human being. They’ve created huge suffering and huge loss of dollars and people’s lives,” Pfeffer said.
Class 2 okay for compartmental monitors
The panel agreed, with one abstention, that general and special controls provided with class 2 designation would be adequate for intracompartmental pressure monitors, which are used to diagnose and monitor compartment syndrome that occurs following trauma, and most often, as an FDA representatives noted in his overview, are due to tibial fractures.
In his comments, surgeon Frank R. Lewis Jr., MD, executive director emeritus of the American Board of Surgery and a temporary voting member of the panel, agreed with the other panelists that the monitors were suited to be class 2 devices. “I think the current specifications are, if anything, excessive, and it possibly could even be a class 1 device,” Lewis said.
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