FH Ortho Gains Approval for New Arrow Reverse Shoulder Plates

French company FH Orthopedics Inc., an orthopedic device maker commonly known as FH Ortho, has earned premarket approval from the U.S. Food and Drug Administration (FDA) for the Arrow reverse shoulder “long keel” and “short keel” glenoid base plate. The long keel base plate has been used for the past four years in France, especially for complicated cases.

The Arrow reverse shoulder long keel and short keel glenoid base is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

“FDA approval of the ‘long keel’ and ‘short keel’ glenoid bases further expands the value and versatility of the Arrow system for surgeons,” said Jim Hook, managing director of FH Ortho’s U.S. operations. “Now, surgeons whose patients may have been told they are not good candidates for shoulder replacement, or even revision of a previous replacement, have an effective and proven new option for returning vitality and mobility to the patient’s life.”

The Arrow total shoulder joint replacement system is a universal system for shoulder arthroplasty, allowing surgeons to implant a reverse or anatomical prosthesis using the same set of instruments. The total system was approved by the FDA in November 2010.

“With the FDA’s approval to add the long keel glenoid base plate to the Arrow System, we can now give the surgeon additional options for patients with severely compromised glenoids,” added Hook. “The strength of fixation, as well as an outstanding fixation base for bone grafting provides the shoulder surgeon with a new tool in treating the patient with debilitating conditions associated with glenoid deformities.”

FH Ortho’s U.S. offices are in Chicago, Ill.