Continuing its path of various regional clearances in 2017, OrthAlign received Australian Therapeutic Goods Administration approval of its handheld surgical navigation technologies, DAA HipAlign® for Direct Anterior Approach Total Hip procedures, and UniAlign® for Partial Knee Arthroplasty. This is in addition to CE Mark Approval, approval from the Japanese Ministry of Health, Labour and Welfare and FDA clearances.
DAA HipAlign and UniAlign will be included among OrthAlign Plus® handheld navigation devices, along with KneeAlign® and Posterior HipAlign® technologies. To date, OrthAlign technology has been used in >65,000 cases, in >25 countries, with more than 15 published international clinical studies.
Sources: OrthAlign, Inc.; ORTHOWORLD Inc.