Search Results

The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:
• Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
• Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component.

Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patient-specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component indudes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or a highly cross-linked Vitamin E infused polyethylene (iPoly XE™) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE).

For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.

The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510(k) K122870.

This device is not an AI/ML device, and therefore the acceptance criteria and study information is not applicable in the requested format.

The ConforMIS iTotal® CR Knee Replacement System (iTotal CR KRS) is a traditional medical device (a knee replacement system) and not an AI/ML powered device. The document describes a 510(k) summary for a modified version of an already cleared device, focusing on demonstrating substantial equivalence to the predicate device.

The "testing" mentioned is non-clinical laboratory testing to establish substantial equivalence for the modified device, specifically:

• Patella fixation testing
• Steam Sterilization Validation and Product Performance for metal implants and iJig Instrumentation post steam sterilization to support instructions provided for sterilization of components in case of a loss of sterility.

These are standard engineering and sterilization validation tests for physical implants and instruments, not performance metrics for an AI/ML algorithm. Therefore, the requested information about acceptance criteria, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are irrelevant to this submission.

Ask a specific question about this device