OrthAlign receives KneeAlign™ Market Clearance from US FDA

Aliso Viejo, CA – March 25, 2010 – OrthAlign, Inc., a privately held medical device company in Aliso Viejo, CA, received 510(k) market clearance from the US Food and Drug Administration for the latest design of its palm-sized disposable KneeAlign™ computer assisted system for total knee arthroplasty.

“We are encouraged by clinicians’ positive reactions to our pre-clinical and early clinical data showcased during the American Academy of Orthopaedic Surgeons earlier this month” said Pieter Wolters, President and CEO of OrthAlign: “Now that we have market clearance for the KneeAlign system, we will be launching the product in the US.”

About OrthAlign, Inc.:
OrthAlign is committed to providing orthopedic surgeons with user-friendly, cost-effective, surgical navigation products for precise alignment. We believe that our technology will raise the standard of care in joint surgery by making consistent and measurable results accessible to all surgeons, hospitals and patients.

In January 2010, OrthAlign concluded its Series A financing round with a $5.2 million Series A2 tranche led by California Technology Ventures (Pasadena, CA). Additional participants included existing investors: Research Corporation Technologies (Tucson, AZ) and Okapi Venture Capital (Laguna Beach, CA). The funds will be used to support the commercial launch of the KneeAlign™ system in 2010 and to continue developing other products in our pipeline.

For more information, visit our new website:


Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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