Exactech's new Equinoxe shoulder system has received 510(k) clearance from the US FDA. The Equinoxe Shoulder System includes primary implants designed to provide surgeons with anatomic precision as well as a straightforward technique and a robust scope that maximizes intraoperative flexibility.

The system's fracture stem is based on significant anatomic study and represents a new generation in the treatment of complex fractures of the shoulder. The company said that surgeon training would be carried out in November with clinical evaluation cases scheduled for December. The full market release is scheduled for the first quarter of 2005, the company informed.

Exactech executive vice president of Research and Development Gary Miller said, "The Equinoxe shoulder system has several patented design features that offer the surgeon solutions to the problems of humeral arthritis and proximal humeral fractures. The primary prosthesis offers multiplanar adjustability to facilitate intraoperative reproduction of the individual patient's anatomy and soft tissue balancing. The fracture prosthesis is tailored to the anatomy to enhance bony reconstruction. These features will be helpful to the surgeon in improving patient outcomes."

Exactech executive VP, sales and marketing David Petty said, "Although there are numerous competitors in the shoulder market, we are confident that our differentiated system will make a valuable contribution in 2005. The system was developed in conjunction with a team of shoulder surgeons that includes the past president of the American Shoulder and Elbow Surgeons. The detailed, hands-on surgeon involvement in the design process helped us develop a system that solves specific clinical problems important to the surgeons."

The US shoulder arthroplasty market involves approximately 25,000 implants per year and generates approximately $100 million in revenue per year.

Based in Gainesville, Florida, Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians.