Klassic Knee System - Revision Tibial Baseplate

The Klassic Knee System – Revision Tibial Baseplate is a titanium alloy (Ti6Al4V) component designed for use in total knee arthroplasty procedures. It is intended for prosthetic replacement in patients with degenerative joint disease, inflammatory arthritis, failed prior knee surgery, or revision of previously failed knee implants, and is indicated for cemented fixation.

The device uses the same material (Ti6Al4V per ASTM F136), the same intended use (primary or revision total knee arthroplasty), and the same gamma sterilization method as the predicate Klassic Tibial Baseplate devices (K112906, K230537). It is introduced as a line extension with equivalent design and function.

ASTM F3334-19 (fatigue analysis), ASTM F1800 (modular interface fatigue testing), ASTM F2052-21 (MRI safety), ASTM F2213-17 (MRI safety), ASTM F2182-19e2 (MRI safety), and LAL testing for orthopedic implants. Post-fatigue disassembly torque testing per internal protocol and fretting corrosion analysis per Goldberg Criteria and Fricka et al. were also performed.

The revision tibial baseplate maintains identical material composition, sterilization method, and intended clinical applications as the predicate devices. Non-clinical testing including fatigue analysis, modular interface testing, and fretting corrosion analysis demonstrated that the subject device meets pre-determined design acceptance criteria and performs comparably to the predicate, establishing substantial equivalence based on equivalent design, materials, and demonstrated safety and effectiveness.