iTotal® G2 The only individualized total knee system on the market today

1 in 5 patients are not satisfied with the results of their total knee replacement surgery.1

Patient dissatisfaction has two main causes: residual pain and functional limitations. We think both of these issues can be addressed by a better implant design.

People vary in more ways than gender, race and size. Optimal fit and performance requires an individualized approach. The ConforMIS iFit® image-to-implant™ technology allows us to convert patient imaging data into individualized, patient-specific implants and instruments with unique advantages not achievable with off-the-shelf knee implants.

This proprietary technology, coupled with the belief that instruments and implants should be unique to the patient, help us create an "individualized experience" in four key areas.

Individualized Fit

Femoral overhang of greater than 3mm has been shown to be a significant cause of residual pain in total knee replacement, affecting 40% of men and 68% of women in one study.2

The iTotal G2 is uniquely qualified to address the wide variations in patient anatomy that lead to overhang and undercoverage. By following the anatomic structure of each patient, the iTotal implant is designed to fit one knee and only that knee.

  • Individualized fit that eliminates sizing compromises
  • Designed to follow the contour of each patient's anatomy
  • Tibial tray designed for maximized cortical rim coverage with pre-navigated rotational alignment


iTotal G2 is designed to follow the contour of each patient's anatomy

 

Individualized Shape

Shape drives kinematics.

Studies show total knee replacements, including single radius designs, alter patient kinematics, leading many patients to report their knee does not feel "natural." In fact, dissatisfied patients report that their knee does not feel normal at more than 2x the rate of satisfied patients.3

iTotal G2 starts with each patient's own "J" curves, corrected for deformity as the basis for implant design. Matching the patient's condylar geometry and preserving their medial and lateral joint line provides each patient with the potential for a more natural feeling knee.

  • Individualized condylar and trochlear J-curves with matching offset poly inserts
  • Designed for optimal bone preservation
  • Wear optimized by matching femur and tibial inserts for maximized surface contact area

Simplified Surgical Technique

Efficient. Reproducible. Effective.

ConforMIS iJigs® and iViews® provide the basis for a reproducible simplified surgical technique. Unlike other total knee systems that stop at just two initial patient-specific blocks, the iTotal G2 uses the patient data to enable an entire surgical technique using pre-navigated jigs.

iJigs facilitate each step of the surgical technique with precise, anatomically matched instruments that facilitate accurate cuts and component placement. iJigs are individualized from the patient's imaging data to simplify many of the sizing and alignment steps used in standard knee replacement surgery.

iView surgical planning images help visualize instrument and component placement for each key step in the procedure, with detailed resection values that can be used to verify accuracy throughout the surgery.


                                                                                                   iView Surgical planning images

Improved OR Efficiencies

When it comes to efficiency in the operating room, less is more.

The iTotal G2 is delivered in a single, pre-sterilized kit a few days before surgery.

  • Reduced sterilization and inventory costs
  • Disposable system delivered in a single pre-sterilized box
  • Minimal instrumentation required
  • Simplified set-up and tear down

 

Intended Use

The iTotal G2 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, patellafemoral or bicompartmental prosthesis.

The Indications for Use include:

  • Painful joint disease due to osteoarthritis, traumatic arthritis or 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, hemiarthoplasties, and unicondylar, patellafemoral or bicompartmental implants.

The iTotal G2 implant is intended for cemented use only.

Contraindications

The following conditions are absolute contraindications for tricompartmental knee repair.

  • Active or recent local or systemic infection.
  • Insufficient bone stock on the femoral or tibial surfaces.
  • Skeletal immaturity.
  • Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustifiable (e.g., absence of musculoligamentous supporting structures, joint neuropathy).
  • Severe instability due to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
  • Severe (>15 degrees) fixed valgus or varus deformity.
  • Metal sensitivity (e.g., nickel).

Footnotes:
1Bourne, R.B., et al; Patient Satisfaction after Total Knee Arthroplasty. Who is Satisfi ed and who is not? Clinical Orthopaedics and Related Research: 2010.
2Mahoney, 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
3 Noble, et al; Patient Expectations Affect Satisfaction with Total Knee Arthroplasty. Clinical Orthopaedics and Related Research; 2006, 452: 35-43