Moirai Orthopaedics received approval from the FDA for its investigational device exemption application to initiate a clinical study of its Pyrocarbon Implant Replacement System, according to a News-Medical report.
The PIR System, a single-component implant, is intended for the treatment of articular cartilage defects of the medial femoral condyle. The clinical study will evaluate the safety and efficacy of the device, and it will begin in the summer of 2015. The first implantations will be performed by Deryk Jones, MD, section head of sports medicine at the Ochsner Sports Medicine Institute in New Orleans, according to the report.