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The Freedom® Total Knee System is indicated for the following:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components, and Primary PCK Components, and Metaphyseal Cones only).

The Freedom Porous Tibial Base Plate, and Cementless Femoral Components, and Metaphyseal Cones are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.

The Freedom Metaphyseal Cones are additionally indicated for use in addressing tibial bone voids and/or metaphyseal reconstruction.

The subject device, Freedom Knee Metaphyseal Cone implants, is a component addition to the cleared Freedom Total Knee System for addressing tibial bone voids and/or metaphyseal reconstruction. The Freedom Knee Metaphyseal Cone implants are designed with an elliptical shape, scaling larger in the Medial-Lateral (ML) direction than the Anterior-Posterior (AP) direction. The sizes are driven by the ML size, ranging from 25mm to 60mm wide in the ML direction and 29mm to 36mm AP in the AP direction. The cones are all 30mm long and feature a stepped design to further enhance the stability in the proximal-distal direction.

The Freedom Knee Metaphyseal Cone implants feature a large internal diameter to accept the largest possible Freedom Knee Stemmed Tibial Baseplate and Stem Extension possible. The internal diameters grow larger with each implant size, and all feature cement pockets to enhance the stability of the eventual TKA construct. The cone implants also feature 12mm wide relief slots to accept the fins/keel of the Freedom Knee Tibial Baseplate.

The AP and ML sides of the cone implants (which contact the metaphyseal bone) feature a 1mm thick proprietary scaffold structure. This structure, only possible via the additive manufacturing process, is designed to mimic the size and porosity of cancellous bone. The implant is comprised of Ti6Al4V ELI metal certified to ASTM F3001 and is manufactured with significant surface roughness to further add to the hydrophilic nature of the implant.

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