OrthAlign Receives KneeAlign® 510(k) Market Clearance from US Food and Drug Administation

Contact: James Young Kim FOR IMMEDIATE RELEASE: October 7, 2009
OrthAlign, Inc. Download PDF
Tel: 949-525-9027
jkim@orthalign.com

OrthAlign Receives KneeAlign® 510(k) Market Clearance from US Food and Drug Administation

Irvine, CA – October 7, 2009 – OrthAlign, Inc., a privately held medical device company in Orange County, CA, received a 510(k) market clearance letter from the US Food and Drug Administration, confirming that its KneeAlign® disposable computer-assisted surgical (“CAS”) navigation system for total knee arthroplasty procedures is substantially equivalent to currently marketed CAS systems.

About OrthAlign, Inc.

OrthAlign is a privately held medical device company committed to providing orthopedic surgeons with user-friendly, cost-effective, surgical navigation products for precise alignment. We believe that our technology raises the standard of care in Total Knee and Total Hip Arthroplasty surgeries by making consistent and measurable results accessible to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precise alignment solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit www.orthalign.com.

ORTHALIGN®, ORTHALIGN PLUS™, KNEEALIGN® are [registered] trademarks of OrthAlign, Inc.”