ConforMIS has received the US Food and Drug Administration (FDA) 510(k) clearance, to commercially market its iTotal CR Knee Replacement System.
The iTotal CR builds on ConforMIS’ patented iFit technology for generating patient-specific implants and individualized jigs.
The system uses computer modeling to build a 3D image of a patient’s knee from CT scans, which guides the design and manufacture of not just the jigs, but the personalized implants that resurface the patients’ articular surfaces.
The iTotal CR is engineered to preserve more bone than than the traditional total knee replacement (TKR) system and helps in improving fit.
The design software generates medial and lateral articulating surface geometries for each patient that more closely mimic a patient’s natural geometry while correcting for deformity.
ConforMIS CEO Philipp Lang said the iTotal 510(k) clearance marks a new phase in ConforMIS’ leadership of the patient-specific category by expanding their product line to address the full range of opportunities in the multi-billion dollar knee market, the largest segment in orthopedics.