OrthAlign commenced full commercial launch of UniAlign™, the first handheld navigation device for unicompartmental knee arthroplasty.
UniAlign received FDA 510(k) clearance and entered beta launch in 1Q16. The system 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. It is an open platform and requires no pre-op imaging or custom cutting guides, and its resection accuracy has been validated with at least 90% confidence.
OrthAlign's handheld navigation technology and instruments have been used in ~60,000 joint arthroplasty cases worldwide, to date, and include:
- KneeAlign® and KneeAlign 2 for tibial and femoral navigation in total knee arthroplasty; compatible with all implant systems
- The Direct Anterior Approach HipAlign® system, FDA 510(k) cleared in 1Q17
Also within 1Q17, OrthAlign reported 2016 sales growth at 30% over 2015, with ex-U.S. growing 43% year over year, and appointed Mr. Eric Timko as CEO.
OrthAlign will showcase its full portfolio of products, including UniAlign and Direct Anterior HipAlign technologies, at this year’s AAOS meeting.
Sources: OrthAlign, Inc.; ORTHOWORLD Inc.