The KneeAlign™ system is a palm-sized, surgical
navigation system for tibial alignment in total knee
arthroplasty (TKA). The KneeAlign™ system is compatible
with all TKA implant systems and is the culmination of
an intensive product development effort guided by the
efforts of highly regarded knee surgeons. As part of
this rigorous, iterative process, the KneeAlign™ system
was fine-tuned in both cadaveric and clinical cases.
The KneeAlign™ system has received
510(k) clearance from the FDA as being substantially
equivalent to large console computer-assisted
surgery systems, for tibial measurement.
Large console computer-assisted surgery systems have
been shown to significantly reduce the risk of poor
alignment in TKA compared to conventional
instrumentation - the current standard of care.
The KneeAlign™ system combines the alignment precision of
large console computer-assisted surgery systems with the
simplicity of conventional instrumentation. It requires
no capital expenditures and, based on clinical
experience, entails only a short learning curve,
allowing the surgeon and hospital to quickly evaluate
the system at minimal cost.