The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Tuesday, April 24, 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 Link America, Inc., for the Scandinavian Total Ankle Replacement (STAR) System (P050050). This device is a first-of-a-kind, non-constrained, mobile-bearing ankle prosthesis intended for use as a non-cemented implant to replace a painful arthritic and/or severely deformed ankle due to rheumatoid arthritis, primary arthrosis, or posttraumatic arthrosis.
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 Scandinavian Total Ankle Replacement (STAR) System by demonstrating non-inferiority to a control arthrodesis treatment. Patient success was defined as a 40 point increase from baseline on the Buechel-Pappas (BP) Scale, while the safety composite success consisted of no device failures, revisions or removals, radiographic success, and no major complications. The Scandinavian Total Ankle Replacement (STAR) System study results were found to be non-inferior to the arthrodesis control.
The Panel voted (4-2-0) to recommend that the PMA application for the Scandinavian Total Ankle Replacement (STAR) System be found “Approvable with Conditions.” The recommended conditions of approval are summarized as follows:
1. There should be a post approval clinical study with independent radiographic assessment to evaluate the long-term safety and performance of the ankle prosthesis.
2. There should be an update to the surgical manual to reflect modifications not yet implemented but described by the applicant.
3. There should be pre-clinical studies to validate the applicant’s proposed weight limit.
4. There should be patient education to describe the warnings contained in the package insert in layperson terminology.
5. “Severely deformed” terminology should be removed from the indications for use, and primary arthrosis should be replaced with degenerative arthritis in the indications for use.
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