OrthAlign Receives Market Clearance for KneeAlign

OrthAlign, Inc., a privately held medical device company in Aliso Viejo, Calif., has received 510(k) market clearance from the U.S. Food and Drug Administration for the latest design of its palm-sized disposable KneeAlign computer-assisted system for total knee arthroplasty, according to an OrthAlign news release.

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“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” Pieter Wolters, president and CEO of OrthAlign, said in the release. “Now that we have market clearance for the KneeAlign system, we will be launching the product in the U.S.”

Read the OrthAlign release about KneeAlign.

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