OrthAlign Receives FDA Clearance for UniAlign in Unicompartmental Knee Arthroplasty

By Julie A. Vetalice

OrthAlign received FDA 510(k) clearance to market UniAlign™, a handheld, single-use navigation device for Unicompartmental Knee Arthroplasty (UKA). Product launch is slated for mid- to late-Summer 2016.

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. It is open platform, and requires no pre-op imaging or custom cutting guides.

UniAlign is based on the company's KneeAlign® technology that has been used in >40,000 TKAs worldwide, to date.

Source: OrthAlign, Inc.

Product Labels: Knee Replacement, Surgical Navigation

Tags: 510(k) Clearance, Regulatory