FDA Clears Orthalign’s Single-use Surgical Navigation System

The U.S. Food and Drug Administration (FDA) has granted Orthalign Inc. 510(k) clearance for its Orthalign Plus system, a palm-sized single-use navigation device for total hip arthroplasty (for both anterior and posterior approaches) and total knee arthroplasty surgeries.

Orthalign plus is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The system is designed to facilitate the accurate positioning of implants relative to these alignment axes.

“The FDA’s clearance of the Orthalign Plus system provides an important new alternative in navigation technology for surgeons, specifically in total hip arthroplasty surgery,” said Nick van der Walt, Orthalign’s vice president of engineering. “Many surgeons have shared with us their challenges in being able to consistently position the acetabular cup at the desired inclination and anteversion. We are now uniquely able to provide surgeons with the tools they need to address those challenges and dramatically improve total hip arthroplasty alignment.”

For total hip arthroplasty surgery, the Orthalign Plus system provides a reported measurement accuracy of ±3°, with at least 95 percent confidence when measuring the angle of the shell impactor, relative to the frame of reference defined by the registered landmarks. The device has been tested and validated to achieve acetabular shell navigation accuracy for both inclination and anteversion.

“Cup orientation with conventional instruments has been challenging,” said said David J. Mayman, M.D., clinical co-director of the computer assisted surgery center, Hospital for Special Surgery, New York, NY. “While navigation systems have been available for over a decade and are known to improve accuracy, adoption has been low due to high capital equipment cost and disruption to surgical workflow. The OrthAlign Plus system provides comparable accuracy without these drawbacks.”

For total knee arthroplasty surgery, Kneealign 2 is fully integrated into the Orthalign Plus system, continuing to provide a reliable and efficient alternative to expensive computer assisted surgery (CAS) systems, logistically arduous patient-specific cutting blocks, and invasive conventional methods used with an intramedullary rod. According to the company, Kneealign has successfully been used in over 12,000 total knee arthroplasty cases to date, demonstrating its accuracy to be comparable to traditional CAS systems, while providing better accessibility through greater ease of use, no need for capital investment, and significant lower cost per case.

“Just as we have with the engineering of our Kneealign system, Orthalign has maintained its product development focus on providing accurate results, while fitting within the surgeon’s normal workflow and without significantly increasing procedure time,” continued van der Walt. “We are looking forward to the full commercial rollout of our Orthalign Plus system.”

Based in Aliso Viejo, Orthalign makes surgical navigation products.