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 … Read the rest