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

April 27, 2015 |

4 min read

Approval Certain To Be Welcome News For Surgeons With Patients Suffering Severe Shoulder Arthropathy Or Requiring Revision On A Previously Failed Shoulder Joint Replacement

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.

“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”

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.

About FH Ortho

FH Ortho makes thoughtfully designed orthopedic devices, instruments and procedures for surgeons around the world. Founded in 1964, in Mulhouse, France, FH Orthopedics products are focused on joint reconstruction, ligament repair, biologics, foot & ankle, spine, and trauma surgery. Backed by 50 years of forward-thinking innovation in not only devices and technique, but even in the way products are shipped, stored and deployed in the O.R., the company is today positioned for rapid growth and expansion in the United States, where FH Ortho is focused on knee ligament repair and shoulder arthroplasty. There are additional products awaiting approval that will address additional orthopedic treatment areas.

Backed by insight that comes from tens of thousands of surgical cases, decades of research and impressive clinical results, FH Ortho products are sought after for their benefit to not only the surgeon and patient, but also to the medical center where the patient is treated.

FH Ortho products are developed and refined by surgeon experts who are among the world leaders in their respective fields. Prized for elegant design and distinguished by clinical sophistication and flexibility, FH products help surgeons deliver ideal patient outcomes with devices, systems and tools that simplify things for the surgeon, at an overall cost structure that is a benefit to the medical center and the community.

With an unrelenting commitment to innovation, research and collaboration, FH continues to bring new ideas and techniques to advance the forefront of orthopedics globally.

Learn more at www.FHOrtho.com.

Note to editors: Product photography available upon request.