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Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis. The ankle prosthesis is additionally indicated for patients with a failed previous ankle surgery. CAUTION: The ankle prosthesis is intended for cemented use only.

The Topez prosthesis is a total ankle joint replacement medical device. It is a semiconstrained, cemented prosthesis. It is intended to be an equivalent product to the DePuy's FDA-cleared "Agility" model, with the same indications for use. Components: Listed below are the components comprising the Topez ankle prosthesis assembly. - 1. Tibial-side replacement (tibial platform): This is a titanium (Ti-6A1-4V, ELI) structural component that holds and secures the Ultra High Molecular Weight Polyethylene (UHMWPE: GUR 1020, ASTM F648) component and interfaces with the Tibial Stem Assembly (both described below) - 2. UHMWPE: This is a concave component that replaces the physiological distal end of the tibia. It is one of the two major bearing surfaces in the ankle joint replacement system. The UHMWPE snap-locks within a tibial platform using a design similar to knee replacement systems. - 3. Tibial Stem Assembly: This is a titanium (Ti-6Al-4V, ELI) anchor-interface by which the tibial platform component is secured to the tibia. It consists of 4 titanium cylinders that are screwed together to form a long stem up within the center of the tibia. There are four components to be inserted through a small anterior incision in the ankle, screwed together and then pushed up into the center of the drilled tibia. The 4-stem assembly is finally secured to the tibial platform with a Morse taper lock system that is common with joint implants. - 4. Talar-side replacement (talar platform): This is a convex Cobalt-Chrome (Co-Cr-Mo, ASTM F1537) bearing surface on the talar side of the ankle joint. In concert with the UHMWPE, it forms the sliding-rotating joint interface of the ankle joint. It serves the second function of providing the interface-anchor to the talus. - 5. Talar Stem: This is a titanium (Ti-6Al-4V, ELI) anchor-interface by which the talar platform component is secured to the talus. The Talar Stem is attached to the Talar platform with a Morse taper lock system that is common with joint implants. The Topez prosthesis is comprised entirely of materials now used for other implant products. The Topez ankle is intended to be used with a tibial anchor that is larger than those that are typically seen with ankle prostheses. The Topez ankle utilizes a Foot-Leg holder assembly with jigs and fixtures intended to assist the surgeon with an accurate and simple prosthesis installation tool-kit.