OrthAlign, Inc. Announces US FDA Clearance for UniAlign™, the world’s first handheld navigation device for use in Unicompartmental Knee Arthroplasty
OrthAlign, Inc., a privately held U.S.-based medical device company, received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its UniAlign™ system, the world’s first handheld, single-use navigation device for Unicompartmental Knee Arthroplasty (UKA) surgeries.
UniAlign establishes the mechanical axis of the tibia, determining the 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 for 90% of the population.
“The FDA’s clearance of UniAlign finally provides surgeons who are involved with Unicompartmental Knee Arthroplasty surgeries a practical navigation technology for everyday use,” said James Young Kim, OrthAlign’s Global Vice President of Sales & Marketing. “Surgeons who currently use KneeAlign for Total Knee Arthroplasty surgeries have shared with us that they see true value in an OrthAlign solution for UKAs. While UKAs do require just as much precision as Total Knee Arthroplasty (TKA) procedures, they definitely are not supposed to require expensive capital investment. OrthAlign’s UniAlign offers the perfect blend of performance and affordability for this outpatient procedure and we are excited to bring this technology to market.”
UniAlign was developed using the same technology and platform that OrthAlign’s award-winning and clinically-proven KneeAlign® technology was built on. To date, KneeAlign has successfully been used in over 40,000 Total Knee Arthroplasty cases, worldwide.
Sridhar M. Durbhakula, MD of the Washington Joint Institute in Bethesda, MD states, “UniAlign will be unique in that it is open platform, there will be no need for pre-op imaging or custom cutting guides, no added co-morbidity of extra pin placement, and no issues with line of sight from spheres and tracking. Additionally, UniAlign will make effective and proven technology available to all surgeons, from a price-point perspective.”
“OrthAlign’s precision technology now being offered for a UKA solution will be game-changing,” said Dr. Michael P. Ast, Director of Outpatient Joint Replacement at Mercer-Bucks Orthopaedics in Lawrenceville, NJ. “Having this proven handheld technology in the palm of my hands for each of my UKAs will be extremely valuable and I’m looking forward to getting started. I use OrthAlign technology in every one of my TKAs and will do the same for my UKAs.”
OrthAlign will continue sharing more relevant clinical data and it is expected for UniAlign to be commercially available mid-to-late Summer 2016.