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OrthAlign receives 510(k) clearance for navigation device for THA, TKA
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The FDA has issued 510(k) clearance to OrthAlign Inc. for its OrthAlign Plus system for total hip arthroplasty and total knee arthroplasty.
"The FDA's clearance of the OrthAlign Plus system provides an important new alternative in navigation technology for surgeons, specifically in total hip arthroplasty (THA)," Nick van der Walt, president of engineering at OrthAlign, stated in a company press release. "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 THA alignment."
The system is a palm-sized, single-use navigation device that can be used in both anterior and posterior THA approaches. It 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 in THA. According to the release, the device has been tested and validated to achieve acetabular shell navigation accuracy for inclination and anteversion.
For total knee arthroplasty, KneeAlign 2 is fully integrated into the OrthAlign Plus system, continuing to provide a reliable and efficient alternative to computer-assisted surgery systems, patient-specific cutting blocks and the conventional methods used with an intramedullary rod.