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The iTotal® Identity™ Cruciate Retaining (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 CS insert option should be utilized when additional anterior-posterior constraint is desired.

iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is a patient-specific tri-compartmental faceted knee replacement system. It is a posterior cruciate ligament retaining knee replacement system. It is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components. An optional Cruciate Sacrificing insert may be utilized when additional anterior-posterior constraint is desired.

Using patient imaging (CT 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 includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel cap manufactured from polyethylene (UHMWPE) and either one or two polyethylene inserts. The CS insert is a one-piece insert. The polyethylene inserts may be manufactured from either iPoly® (UHMWPE) or iPoly® XE (a Highly Cross-Linked, Vitamin-E Stabilized UHMWPE). The patellar component is provided in either a round or oval dome shape and may be manufactured from either iPoly® or iPoly® XE.

For user convenience, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal® Identity™ CR KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

The provided text is a 510(k) summary for the iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS), specifically focusing on the new Cruciate Sacrificing (CS) tibial insert. This document asserts substantial equivalence to existing predicate devices, rather than presenting a study proving that an AI/ML powered device meets acceptance criteria.

The information requested in the prompt (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in submissions for AI/ML-powered medical devices that perform tasks like image interpretation or diagnosis. This document, however, describes a mechanical medical device (a knee implant) and its component. The "performance data" section refers to engineering and biomechanical testing, not clinical performance or AI/ML model performance.

Therefore, I cannot extract the requested information from the provided text as it does not pertain to an AI/ML medical device. The document details the device's design, materials, sterilization, and basic performance testing for a physical implant, not an AI/ML algorithm.

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