NovoKnee (SteriKnee)

The NovoKnee (SteriKnee) is a sterile, single-use set of orthopedic manual surgical instruments designed to prepare bone and facilitate implantation of the NovoKnee Total Knee System during total knee replacement surgery. The system is provided pre-assembled and procedure-ready in a sterile, double-barrier package for single-patient use, eliminating the need for reusable instrument trays and intraoperative assembly.

The SteriKnee system is substantially equivalent in design, function, and dimensions to corresponding reusable orthopedic surgical instruments commonly used in total knee arthroplasty. The primary technological difference is that SteriKnee is provided as a sterile, single-use, pre-assembled instrumentation kit rather than reusable instruments requiring cleaning, sterilization, and assembly.

Non-clinical performance testing included mechanical and functional verification, packaging validation per ISO 11607, and sterilization validation using ethylene oxide (EtO) to achieve a sterility assurance level (SAL) of 10⁻⁶.

The SteriKnee system instruments demonstrate substantial equivalence to the predicate reusable orthopedic surgical instruments because they perform the same functions, are used in the same manner, and have the same fundamental design characteristics and operating principles. Non-clinical testing confirms the instruments meet intended use, materials, and performance specifications equivalent to the predicate devices.