The FDA granted five PMA (premarket application) supplemental approvals in April, including two post-approval study protocols.
FDA Grants Five Ortho Approvals in April
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Secondary
Post-Approval Study Protocols
NuVasive, Inc. received a study approval for its PCM Cervical Disc and Paradigm Spine, LLC, received the study approval for its Coflex Interlaminar Stabilization Device.
Hips and Knee Systems
DePuy Orthopaedics received two supplemental approvals for hip and knee systems.
In knees, DePuy received supplemental approval for an additional inspection step after the In Process Clean (IPC). The inspection will ensure that there will be no remaining polishing agents left on the Attune CR and Attune PS femoral components after the IPC step is performed. The Attune CR and Attune PS femoral components were previously approved as compatible components to the Class III rotating platform Attune tibial components.
In hips, DePuy received supplemental approval for its Ceramax Ceramic total hip system. The device is indicated for noncemented use in skeletally mature individuals undergoing primary total hip replacement surgery for rehabilitation of hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and post-traumatic arthritis.
Biomet, Inc. received supplemental approval to amend the in-process inspection criteria used at the Warsaw, Indiana site, to include additional dimensional checks after the polishing step for the Oxford Tibial Tray, to align with the Warsaw facility’s standard practices.
Agency Performance Summary
The agency currently has 50 PMAs under review, with 35 of those on hold. It also has 613 supplementals under review, with 176 of those on hold.
Since the beginning of the year, the agency has approved 51 applications, including supplementals, with an average time of 179 days from receipt of the application to a decision point.
To view the FDA’s entire April list of approvals, click here.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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