OrthAlign Receives Japan Approval for Direct Anterior HipAlign and UniAlign

By Julie A. Vetalice

OrthAlign received approval from the Japanese Ministry of Health, Labour and Welfare to market Direct Anterior HipAlign® for use in supine position Total Hip Arthroplasty and UniAlign™ for Unicompartmental Knee Arthroplasty, to be distributed by Zimmer Biomet Japan.

Company leadership cites ~20,000 supine position THAs and 8,000 UKAs completed in Japan during 2016, and notes that these are the fastest-growing joint replacement procedures in the region.

HipAlign is designed to provide accurate cup placement positioning and does not require pre-op imaging, intraoperative fluoroscopy or additional personnel in the OR to control components outside of the sterile field. 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 abduction and anteversion angles of the acetabular cup.

UniAlign establishes the mechanical axis of the tibia, determining varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia for the transverse resection. The system has been validated in simulated use testing to achieve resection accuracy of ±2.0° in the coronal plane, ±3.0° in the sagittal plane and ±2.0 mm in depth. This accuracy has been validated with at least 90% confidence.

Sources: OrthAlign, Inc.; ORTHOWORLD Inc.

Product Labels: Hip Replacement

Tags: Regulatory