OrthAlign, Inc. Announces FDA Clearance for Direct Anterior Approach HipAlign

Aliso Viejo, CA – January 25, 2017 – OrthAlign, Inc., a privately held U.S.-based medical device and technology company, received 510(k) clearance from the United States Food and Drug Administration (FDA) to commercialize its Direct Anterior Approach HipAlign® system. The handheld computer provides surgeons with critical measurements they need to optimize the outcomes of their direct anterior approach total hip replacement surgeries. This is accomplished with cup placement accuracy data and measurement changes in leg length and joint offset.

Based on FDA cleared bench test data, HipAlign technology provides cup placement accuracy of ±3°, with at least 97% confidence. The system accounts for pelvic tilt when measuring the abduction and anteversion angles of the acetabular cup. Additionally, the system measures changes in leg length and joint offset, within 3mm or less, with at least 97% confidence.

“The required surgical technique for Direct Anterior HipAlign is so simple and intuitive. One of the biggest value props is that I can now eliminate the need for intraoperative radiation exposure by getting fluoro out of the operating room. I can’t emphasize how game-changing that is…,” said E. Matthew Heinrich, MD of Orthopedic Specialists of Austin, in Austin, TX. “OrthAlign technology has been one of the most cost-effective, mobile, and accurate technologies in the orthopedic market since I started my practice over 15 years ago. I use KneeAlign® technology for all of my knees and will be using HipAlign for all of my hips.”

Recent statistics have shown that the direct anterior approach, despite being a more challenging surgery, is growing in popularity amongst surgeons as it arguably leads to quicker recovery, less pain, and more normal function for patients after a hip replacement. HipAlign for the Direct Anterior Approach was designed specifically to help surgeons more easily make the transition from posterior to direct anterior, while providing more clinically relevant positioning for cup placement, leg length, and joint offset. HipAlign is an open platform, so it can be used with any THA implant system. The technology does not require any pre-operative imaging, intraoperative fluoroscopy, or any additional personnel in the operating room to control components outside of the sterile field.

“There are three key principles that OrthAlign focuses on in product development: ease of use, precision, and cost-effectiveness,” said James Young Kim, OrthAlign’s Global Vice President of Marketing. “We are so proud of our newest application Direct Anterior Approach HipAlign. Our engineers set out to create a product that will enhance the surgical experience for direct anterior hip replacements and drive better accuracy for the best outcomes, all while fitting in the surgeon’s common workflow. Best of all, especially in this cost-conscious healthcare environment, OrthAlign technology is a fraction of the cost of competing technologies. There are no upfront capital expense requirements, no software costs, and no annual service contracts.”

OrthAlign will be showcasing its full portfolio of products, including the recently approved Direct Anterior HipAlign technology at this year’s AAOS meeting in San Diego, CA, March 15-18, 2017 at booth #5615.

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, committed to providing orthopedic surgeons with cutting edge, user-friendly, surgical navigation products for precise alignment and positioning. We believe that our technology will raise 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 precision-driven solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit

ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN® and UNIALIGN™ are [registered] trademarks of OrthAlign, Inc.”

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