Orthopedic devices maker FH Ortho has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Arrow Reverse Shoulder long keel and short keel glenoid base plate system.
The base has been developed 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.
FH Ortho US operations managing director Jim Hook said: "FDA approval of the ‘long keel’ and ‘short keel’ glenoid bases further expands the value and versatility of the Arrow system for surgeons.
"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."
A functional deltoid muscle and adequate glenoid bone stock are essential to use the device, and 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.
FH Ortho plans to make the product available for the US customers from this month only and it has been used for the past four years in France.
The firm’s Arrow Total Shoulder Joint Replacement System received FDA approval in November 2010. It has been developed for shoulder arthroplasty, which allows surgeons to implant a reverse or anatomical prosthesis using the same set of instruments.