FH Ortho Receives FDA 510(K) Clearance for Its Arrow® Reverse Shoulder Long Keel & Short Keel Glenoid Base

CHICAGO–(BUSINESS WIRE)–FH Ortho, maker of thoughtfully designed orthopedic devices, instruments and procedures for orthopedic surgeons around the world, announces it has received approval from The U.S. Food and Drug Administration to market the ARROW Reverse Shoulder “long keel” and “short keel” glenoid base plate in the United States. 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.”

An innovation by FH Orthopedics, the ARROW Total Shoulder Joint Replacement System is the first universal system for shoulder arthroplasty, allowing surgeons to implant a reverse or anatomical prosthesis using the same set of instruments. Approved by the FDA in November 2010, the ARROW shoulder system is a simple technique that allows patients greater range of motion and a faster recovery.

Thanks to a universal instrument set, surgeons benefit from maximum flexibility in preoperative and intraoperative implant selection. Choice of a “hemi,” “total,” or “reverse” is convenient and easy to make. Furthermore, the ARROW Shoulder System allows for conversion of a hemi prosthesis into a total shoulder or a reverse shoulder without switching out the stem, which prevents incremental trauma and saves surgical time.

“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.”

The newly approved products were shown to surgeons attending the recent American Academy of Orthopaedic Surgeons Annual Meeting in Las Vegas, and will be available to ship to U.S. medical centers by this month.