Smith+Nephew's LANDMARK device wins FDA 510(k) clearance with first surgical case
Key Insights
Smith+Nephew received FDA 510(k) clearance for its LANDMARK Total Knee System (search), an anatomy-driven knee replacement designed to replicate healthy knee anatomy and natural motion.
The first surgical case was completed this week by Dr. Steven MacDonald at London Health Sciences Centre in London, Ontario.
The system pairs with CORI KNEE Handheld Robotics Arthroplasty (search) and is built for both hospital and ambulatory surgery center settings.
Smith+Nephew has received 510(k) clearance from the U.S. Food and Drug Administration for the LANDMARK Total Knee System (search) and has completed the first surgical case with the implant. The system is designed to replicate healthy knee anatomy and the knee's natural motion, supporting a more personalized approach to total knee arthroplasty (search).
Key features include an anatomy-driven design intended to restore natural motion and A/P position with less compromise compared with conventional TKA designs, a smooth flat trochlear groove entry point intended to promote more natural patella tracking, and a fully 3D-printed femoral component using CONCELOC Technology. The implant was designed to leverage the capabilities of CORI KNEE Handheld Robotics Arthroplasty (search), whose compact footprint and mobility suit both hospital and ambulatory surgery center environments.
The first case was performed by Dr. Steven MacDonald, Professor of Orthopaedic Surgery at Western University and London Health Sciences Centre in London, Ontario, who helped design the system. Dr. Steven Haas, Chief of the Knee Service at Hospital for Special Surgery in New York, was also a surgeon developer. Smith+Nephew said the LANDMARK Knee will enter a phased commercial launch focused on early customer adoption, with broader availability across markets expected throughout 2027, and will be presented to healthcare professionals at the AAHKS Annual Meeting in Dallas on November 5-8.
Source: OrthoSpineNews