OrthAlign announces FDA 501(k) clearance for hand-held computer to aid direct-anterior hip replacement

OrthAlign Inc. announced it has received FDA 501(k) clearance for its Direct Anterior Approach HipAlign system.

According to a company press release, the Direct Anterior Approach HipAlign system is a hand-held computer that provides surgeons with critical measurements to optimize outcomes of direct-anterior approach total hip replacement. This is accomplished with cup placement accuracy data and measurement changes in leg length and joint offset. HipAlign reportedly provides cup placement accuracy of plus or minus 3º, with at least 97% confidence. The system accounts for pelvic tilt when measuring abduction and anteversion angles of the acetabular cup. HipAlign also measures changes in leg length and join offset, within 3 mm, with at least 97% confidence. The open platform system does not require preoperative imaging, intraoperative fluoroscopy or additional personnel in the OR 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,” James Young Kim, global vice president of marketing for OrthAlign, said in the release. “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 health care 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.”

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