FDA Clears Intellijoint HIP

Canadian company Intellijoint Surgical Inc. has won U.S. Food and Drug Administration 510(k) clearance for its flagship product, the Intellijoint HIP.

“We’re already approved in Canada, now we can begin marketing Intellijoint HIP to hospitals and orthopedic surgeons in the United States,” said CEO Armen Bakirtzian. “In the United States, similar to Canada, our initial marketing plan is to work closely with certain leading surgeons and hospitals in specific geographic areas. In parallel, we are solidifying alliances with major implant companies while continuing to expand our product line.”

“There are over a half million hip replacements a year in North America, and studies find that 30 percent of patients are dissatisfied with their surgery mainly due to avoidable leg length disparities, implant loosening and failures,” said Wayne Paprosky, M.D., professor and orthopedic surgeon at Rush Medical Center in Chicago, Ill., and member of Intellijoint’s scientific advisory board. “We are very pleased to now be able to use Intellijoint HIP to enhance hip replacement surgery and benefit patients in the United States.”

Intellijoint HIP is a smart tool used to guide surgeons during hip replacement surgery. Its two miniature sensors are placed in the sterile field and communicate with a portable display. Controlled by the surgeon, it quantifies the measurements, often left to subjective judgment, required for selecting and positioning hip implants.

Although Intellijoint HIP does add a few minutes to surgery, it is designed to assure surgeons and patients of obtaining the correct leg length and hip offset, which are the main sources of patient dissatisfaction in hip replacement. For hospitals, currently under pressure to use quality and efficiency metrics, it is hoped to help reduce costs and liabilities of implant failures and repeat surgeries that add over $1 billion a year to the United States’ healthcare system.

Based in Waterloo, Ontario, Intellijoint Surgical is an early stage orthopedic medical device company committed to assist orthopedic surgeons specialized in joint arthroplasty to improve patient care.