NovoKnee (SteriKnee)

NovoKnee (SteriKnee) is an FDA 510(k)-cleared medical device (K261032) manufactured by NovoSource. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 26, 2026. Regulation: 8.