FDA clearance for OrthAlign’s knee and hip navigation device

OrthAlign has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its OrthAlign Plus system, a palm-sized, single-use navigation medical device for total hip arthroplasty (cup placement, leg length, and offset) and total knee arthroplasty (tibial and femoral) surgeries.

“The FDA’s clearance of OrthAlign Plus provides a revolutionary and cutting edge alternative in navigation technology for surgeons who are involved with total hip arthroplasty surgery,” said James Young Kim, OrthAlign’s vice president of marketing. “Surgeons have shared with us their challenges in consistent acetabular cup positioning and confidently measuring leg length and offset. OrthAlign is now uniquely able to provide surgeons with the technology needed to firmly address those challenges and dramatically improve total hip arthroplasty alignment.”

OrthAlign Plus provides measurement accuracy of ±3°, with at least 95% 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 1) acetabular shell navigation accuracy for both inclination and anteversion, 2) measurement accuracy for changes in the femoral position in the superior-inferior direction, and 3) measurement accuracy for changes in the femoral position in the medial-lateral direction.

“The accuracy of navigation for total hip arthroplasty in a simple handheld device has finally become a reality,” said David Mayman, clinical co-director of the Computer Assisted Surgery Centre, Hospital for Special Surgery, New York. “Every surgeon that I speak with wants the accuracy of navigation, but doesn’t want the hassle of a big computer assisted surgery system. OrthAlign Plus makes this possible; it’s really going to change the way that we do hips.”

Additionally, KneeAlign technology will be 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, for total knee arthroplasty surgeries. To date, KneeAlign has successfully been used in over 17,500 total knee arthroplasty cases.

OrthAlign Plus will be commercially available in Fall 2014.