Freedom Total Knee System (All-poly Tibial Plate)

The Freedom Total Knee System All-poly Tibial Plate is a knee replacement component made from a single piece of UHMWPE (ultra-high molecular weight polyethylene) combining the articular surface, tibial baseplate, and stem. It is indicated for treatment of severe knee joint pain and disability from arthritis, correction of deformities, and revision surgery where bone stock is adequate, with cemented fixation.

The new All-poly design retains the single-component construction of prior all-poly implants while upgrading the stem to a larger finned stem/keel design from the modular metal-backed Freedom system (K090411). The anterior-posterior and medial-lateral profiles remain identical to predicate devices. The implants come in multiple articular surface types: Posterior-Stabilized (identical to K082019), Ultracongruent (identical to K182574), and Medial Congruent (identical to K243277).

ASTM F648 standard for GUR 1020 (Type 1) UHMWPE material is cited.

Engineering drawing specifications of the new all-poly implants are equivalent to predicate devices in geometry and material. Mechanical and biological property analyses confirm the Ultracongruent and Medial Congruent components fall within the scope of existing verification testing for predicate devices and do not create new worst-case scenarios for mechanical, cleaning, sterilization, or packaging. The device geometry and articulating surfaces demonstrate equivalent performance properties to predicates, and implantation process, surgical technique, and stability are identical to existing predicate counterparts, therefore no additional clinical validation is necessary.