Individually Customized Total Knee Replacement
DID YOU KNOW: 1 in 5 patients are not satisfied with the results of their total knee replacement surgery.i
Two of the leading causes of dissatisfaction after surgery are residual pain and functional limitations. We think both of these issues can be addressed by a better implant design.
iTotal G2 is designed to achieve unique advantages not possible with off-the-shelf knee implants.
When it comes to fit, close isn’t good enough:
- If the implant extends over the bone by as few as 3mm, that can be a significant cause of pain after surgery. Unfortunately, that’s all too common. One study found that overhang ≥3mm affects 40% of men and 68% of women.ii
- iTotal G2 femoral and tibial implants are designed provide a customized fit specific to your knee, helping avoid sizing compromises that can lead to long-term pain after surgery
- The tibial tray is designed to proper rotation based on the pre-operative CT scan, limiting the potential for rotational errors.
Shape drives function
- The shape of your knee plays an important role in how you bend and extend your knee
- Unlike any other knee replacement on the market, iTotal G2 is designed to mimic the natural shape of your knee, which gives your knee the potential to feel and move more naturally
Designed for optimal bone preservation.
- iTotal G2 has a unique 6-cut design for a thinner implant, which translates directly into bone preservation while not sacrificing implant strength.
- In a comparison to other off-the-shelf total knee implants, iTotal G2 saw 28% volumetric bone preservation.iii
Simplified surgical technique
- Patient data enables a reproducible surgical technique using pre-navigated, disposable iJig instrumentation.
- iView surgical planning images provide detailed resection values that can be used to verify accuracy throughout the surgery.
Improved operating room efficiencies
- iTotal G2 is delivered in a single, pre-sterilized kit a few days before surgery, which means no implant inventory for the hospital
- Pre-sterilized, disposable instruments and a single reusable instrument tray mean easy set up and tear down
The result is a knee replacement so precise that it virtually eliminates sizing compromises common to off-the-shelf knee replacements.
The iTotal CR Knee Replacement System 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. 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 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.
The implant is intended for cemented use only.
Caution: Federal law restricts this device to sale by or on the order of a physician.
i: Bourne, R.B., et al; Patient Satisfaction after Total Knee Arthroplasty. Who is Satisfied and who is not? Clinical Orthopaedics and Related Research: 2010.
ii: Mahoney, et al; Overhang of the Femoral Component in Total Knee Arthroplasty: Risk Factors and Clinical Consequences.The Journal of Bone and Joint Surgery; 2010, 92: 1115-1121
iii: ConforMIS data on file