ConforMIS implants are designed to mimic every aspect of your natural knee – from its shape, to the way it bends and extends. We restore the natural shape of your unique anatomy, corrected for deformity, rather than replacing it with a pre-determined, standardized geometry.
Traditional, “off-the-shelf” knee replacements are manufactured in 6–10 standard sizes. During surgery, the surgeon selects the closest approximate size and makes necessary adjustments to fit the implant to your knee. The result is a knee that is nothing like your own knee. This often can lead to pain or discomfort after surgery.
Our innovative design allows for an implant that is thinner than traditional knee implants. A thinner implant can preserve more of your natural bone, which may be beneficial for future treatment options.1
Multiple studies have shown satisfaction rates with iTotal CR well above the average of 80% seen in off-the-shelf knee patients.2,3
ConforMIS implants and instruments are designed based on each patient’s CT scan. An automated design process maps the size and shape of the knee joint in 3D. Our proprietary software uses that information to design the implants and instrumentation that will match precisely to the 3D model of the knee, correcting the data for any underlying arthritic deformity such as bone spurs, cysts or flattening of the joint.
Our disposable, patient-specific iJig® instrumentation is manufactured using the latest in 3D printing technology. This allows us to develop patient-specific instruments for every step of the procedure.
ConforMIS is the only orthopedic company with just-in-time manufacturing and delivery capabilities. This means that our single-use implant kit is delivered pre-sterilized a few days before surgery, removing the inventory from hospital shelves. This also allows for rapid design improvements that can be implemented immediately.
The iTotal CR and PS Knee Replacement Systems are 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. Only a licensed physician can help you determine the appropriate medical treatment. There are potential risks to knee replacement surgery, and individual results may vary. Before making any decisions concerning medical treatment, consult your physician regarding your options and the risks of those options. The longevity, performance and feel of any knee implant will depend on various factors, including your physical condition, your activity level, adherence to your physician’s instructions, and other factors.
The Indications for Use of iTotal CR include:
The Indications for Use of iTotal PS include:
The implant is intended for cemented use only.
Caution: Federal law restricts this device to sale by or on the order of a physician.
1. In a study by W. Kurtz titled “Patient-Specific Knee Replacement Implants Preserve Bone and Decrease Blood Loss & Swelling” presented at the 2013 BASK Annual Meeting, comparing 66 iTotal patients with 66 patients receiving one off-the-shelf implant brand (Zimmer NexGen), thickness of the femoral (distal and posterior medial/lateral), and tibial (medial/lateral) resections were measured intra-operatively. The average total of all bone resection measurements for iTotal was 27% (14mm) less than for the off-the-shelf total knee. Additionally, the total thickness of the iTotal implants was 25% (15.7mm) thinner on average than the off-the-shelf implants.
2. Katthagen, et al; Comparison of Hospital Metrics and Patient Reported Outcomes for Patients with Customized, Individually Made Vs. Conventional TKA. Presented at the 2015 World Arthroplasty Congress
3. Tait, et al; Outcomes after Customized, Individually Made Total Knee Arthroplasty. Presented at the 2016 ICJR Pan Pacific Orthopaedic Congress