The FDA has cleared FH Orthopedic’s Arrow reverse shoulder long keel glenoid base plate, the French devicemaker announced Monday. The company plans an immediate U.S. launch.
The short keel version of the plate was approved with the Arrow Total Shoulder Joint Replacement System — the first universal system for shoulder arthroplasty — in 2010. The Arrow system enables surgeons to implant a reverse or anatomical prosthesis using the same set of instruments, the company claims.
The long keel plate is indicated for severe shoulder arthropathy patients and those suffering from a grossly deficient rotator cuff, or those with a failed shoulder joint replacement who also have a grossly deficient rotator cuff.
Patients must have a functional deltoid muscle and enough glenoid bone stock to have the device installed. The humeral stem is meant for cemented or cementless application; the metal-back glenoid base plate is meant for cementless application using bone screws for fixation, the devicemaker says.
The long keel plate won CE Mark approval in 2005, a spokesman told Device Daily Monday. — Jason Scott