OrthAlign Receives FDA Clearance for Direct Anterior Approach HipAlign

By Julie A. Vetalice

OrthAlign received FDA 510(k) clearance to market the Direct Anterior Approach HipAlign® system, a handheld computer that provides cup placement accuracy data and measurement changes in leg length and joint offset.

HipAlign was designed specifically to support the transition from posterior to direct anterior approach. The system is an open platform that can be used with any total hip implant, and it does not require pre-op imaging, intra-op fluoroscopy or additional O.R. personnel to control components outside of the sterile field. It includes no upfront capital expense requirements, software costs or annual service contracts.

One year ago, the company commenced limited release of OrthAlign Plus® for Total Hip Arthroplasty for use in the direct anterior hip approach.

Sources: OrthAlign, Inc.; ORTHOWORLD Inc.

Product Labels: Hip Replacement, Surgical Navigation

Tags: 510(k) Clearance, Regulatory