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OrthAlign issued 510(k) clearance for new THA, TKA device

OrthAlign recently announced it has received FDA 510(k) clearance to market its OrthAlign Plus total joint replacement system.

The palm-sized, single-use navigation device can be used for cup placement, leg length and offset in total hip arthroplasty and both tibial and femoral total knee arthroplasty procedures. OrthAlign Plus is designed to help achieve acetabular shell navigation accuracy for both inclination and anteversion, as well as measurement accuracy for changes in the femoral position in both the superior-inferior and medial-lateral directions, according to a company press release.

“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,” James Young Kim, OrthAlign’s vice president of marketing, said in the press release. “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.”