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FDA clears Smith+Nephew's new knee replacement system
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Fusion42 · 22 September 2026 · Fusion42 review
Smith+Nephew received FDA 510(k) clearance for its LANDMARK Total Knee System, which uses a fully 3D-printed femoral component and integrates with the CORI KNEE Handheld Robotics platform. The system aims to improve personalised knee replacement and is planned for phased commercial launch across markets in 2027.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You can now develop knee implants that integrate robotics and 3D printing under current US rules. This opens a pathway to compete in advanced personalised orthopedics with faster route-to-market options.
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1 source · 22 Sep 2026
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