OrthAlign Gains CE Mark Approval for DAA HipAlign and UniAlign

By Julie A. Vetalice

OrthAlign received CE Mark Approval to market the DAA HipAlign® Direct Anterior Approach Total Hip and UniAlign® Unicompartmental Knee Arthroplasty, building on previous availability in Japan and the U.S.

DAA HipAlign does not require pre-op imaging or intra-op fluoroscopy for cup placement and leg length measurement, and early U.S. clinical data has demonstrated a reduction in fluoroscopy exposure by about 45%. Early clinical data from Japan shows cup placement (inclination and anteversion) accuracy of ±10°, with at least 95.9% confidence.

UniAlign establishes the mechanical axis of the tibia for transverse resection. In simulated use, UniAlign has been validated to 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.

DAA HipAlign and UniAlign will be included in OrthAlign Plus® handheld navigation devices.

Last month, the company announced closure of a $10MM Series D financing round that will support expansion of its computer-assisted navigation platform from total knee into partial knee and total hip applications.

Sources: OrthAlign, Inc.; ORTHOWORLD Inc.

Product Labels: Hip Replacement, Knee Replacement

Tags: CE Mark, Regulatory