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OrthAlign, Inc. Receives CE Mark Approval for ORTHALIGN PLUS®, the most complete palm-sized positioning device for use in Total Hip Arthroplasty Surgery: Acetabular Cup Placement, Leg Length, and Joint Offset

Aliso Viejo, CA – February 3, 2015 – OrthAlign, Inc., a privately held medical device and technology company, received CE Mark Approval to market its OrthAlign Plus® system, a palm-sized, single-use positioning device for Total Hip (acetabular cup placement, leg length, and joint offset) and Total Knee (tibial and femoral) Arthroplasty surgeries, in Europe and other countries.
“As OrthAlign finalizes its plans for a formal global launch of OrthAlign Plus, receiving CE Mark approval was a major step in helping drive next steps with many of our international distributor partners, eager to bring the technology into their respective local markets,” said James Young Kim, OrthAlign’s Vice President of Marketing. “Surgeons have shared with us their challenges in consistent acetabular cup positioning and measuring leg length and joint offset. OrthAlign is now uniquely positioned to provide surgeons throughout the world with the latest technology needed to firmly address those challenges and dramatically improve accuracy for Total Hip Arthroplasty surgeries.”
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.
Additionally, KneeAlign® technology will be fully integrated into OrthAlign Plus, 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 25,000 Total Knee Arthroplasty cases, with eight published clinical studies demonstrating its accuracy.
“We have an exceptional development team who validated the system in a clear, comprehensive manner, truly making the approval a straight-forward process. OrthAlign received both FDA (510k) clearance and CE mark approval for OrthAlign Plus within 6 months of each other,” said David Vancelette, OrthAlign’s Director of Quality Assurance and Regulatory Affairs. “This speaks highly of OrthAlign’s team and our technology’s capability to be adopted throughout the world.”

OrthAlign Plus will be commercially available in Q2 2015 and fully demonstrated at this year’s AAOS Annual Meeting, March 25-27, 2015, in Las Vegas, NV, Booth #5452.

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