The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Thursday, February 22, 2007 at the Hilton Washington DC North/Gaithersburg located at 620 Perry Parkway in Gaithersburg, Maryland. The Panel met in order to provide advice and a recommendation on the approvability of the Premarket Approval (PMA) application submitted by Corin U.S.A. for the Cormet 2000 Hip Resurfacing System (P050016) intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative arthritis or inflammatory arthritis.
The meeting began with the Chief of the Orthopedic Joint Devices Branch within the Division of General, Restorative and Neurological Devices giving the panel an update of orthopaedic-related reclassification petitions, guidances and FDA staff changes since the last meeting. The sponsor and FDA presentations focused on clinical data collected on the subject device. The clinical data were collected in a non-randomized, multi-center study intended to assess the safety and effectiveness of the Cormet 2000 Hip Resurfacing System by demonstrating non-inferiority to the control treatment. Patient success was defined by the Composite Clinical Success endpoint of a Harris Hip Score greater than or equal to 80, no revision surgery, radiographic success, and no device-related adverse events. The results were found to be non-inferior to the historical control data for the Howmedica Osteonics ABC Ceramic-on-Ceramic System.
The Panel voted (4-1-0) to recommend that the PMA application for the Cormet 2000 Hip Resurfacing System be found “Approvable with Conditions.” The recommended conditions of approval are summarized as follows:
1. There should be a post approval clinical study that considers issues raised during the discussion, including: duration of the study, radiographic evaluation timepoints, metal ion serum levels and revision rates for a Kaplan-Meier survival analysis.
2. There should be mandatory surgical training associated with this device.
3. The labeling should reflect the risk factors identified by the sponsor (small component size, female gender, a non-osteoarthritis diagnosis, leg length discrepancies and a Harris Hip Score less than 42).
Contact: Ronald P. Jean, Ph.D., Executive Secretary, at 240-276-3676 or firstname.lastname@example.org.
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