A letter about FDA Approvals and Off Label Hip Resurfacing Components by Dr. Gross
The Birmingham (Smith & Nephew, Richards) total HSR was the first to get FDA approval in the US based on an unprecedented FDA decision to approve this implant on the basis of single (developing) surgeon’s foreign data. Cormet 2000 (Corin Ltd., Stryker) total HSR was the first to be approved based on the usual mechanism of a US run Multi-center FDA study (approval 7/2007, I was the lead investigator). Therefore, there are now 2 implants available in the US that have an FDA indication for total HSR.
The Recap/Magnum (Biomet), Conserve Plus (Wright Medical) and ASR (Depuy) are all also FDA approved implants in the USA. They may be legally used … Read the rest