FDA BREAKTHROUGH DESIGNATION

The U.S. Food & Drug Administration (FDA) designated our all-ceramic knee system as a Breakthrough Device in April of 2023.  Our proprietary all-ceramic knee will provide patients with the first-ever FDA authorized non-cemented fully ceramic femoral component that will deliver numerous medical benefits, including the complete elimination of harmful exposure to metal ions present in all current metal knee systems.

The FDA’s “Breakthrough Device” designation is granted to a limited number of medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The indications of use of our ceramic knee system will be the same as current knee systems for cemented and cementless use:

• Non-inflammatory degenerative joint disease, including osteoarthritis, traumatic arthritis, or avascular necrosis;
• Inflammatory degenerative joint disease, rheumatoid arthritis;
• Functional deformity such as varus, valgus or flexion deformities;
• Revision procedures; and
• Fractures that are unmanageable using other techniques.