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The Cardo Medical Total Knee System is indicated for use in individuals undergoing surgery for: - Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; - Revisions of previous unsuccessful knee replacement or other procedures. Additional indications for posteriorly stabilized components: - Ligamentous instability requiring implant bearing surfaces with increased constraint; - Absent or non-functioning posterior cruciate ligament. These devices are single use only and are intended for implantation with bone cement.

The Cardo Medical Femoral Cement Restrictor is only intended for use with Cardo Medical PS femoral components (previously cleared in K081127). The device is an optional accessory and is manufactured from UHMWPE.

The Cardo Medical Ceramic Head components are for use in total hip arthroplasty as a result of: • Hip arthritis caused by rheumatoid disease, non-inflammatory degenerative joint disease, osteoarthritis, and arthritis resulting from biologic or mechanical trauma to the hip, • Correction of functional deformity, • Avascular Necrosis, • Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur, • Difficult clinical management problems involving persistent pain and physical impairment where conventional arthodesis is not likely to achieve satisfactory results. These components are single use only and are intended for implantation with or without bone cement.

The previously cleared Cardo Medical Hip System consists of • commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) femoral stems, • cobalt chrome (CoCr) femoral heads, • commercially pure titanium plasma spray-coated titanium alloy (Ti-6Al-4V) acetabular shells, • ultra-high molecular weight polyethylene (UHMWPE) acetabular inserts, and • titanium alloy (Ti-6Al-4V) bone screws. The proposed devices are a line extension to the previously cleared system to add 32mm and 36mm alumina ceramic femoral heads.