iTotal Cruciate Retaining (C) Knee Replacement System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131019 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iTotal Cruciate Retaining (C) Knee Replacement System is a cruciate-retaining total knee prosthesis designed to replace the knee joint in patients with degenerative or traumatic arthritis. It preserves the anterior cruciate ligament while restoring natural knee mechanics through patient-specific, computer-assisted design to optimize fit and alignment.
This system is supplied as a sterile, single-use implant and is intended for use in orthopedic surgical settings under aseptic conditions. It is MRI-safe and available in custom-fit configurations to minimize overhang or under-coverage. Authorized under FDA 510(k) clearance (K131019), it adheres to orthopedic device standards for total knee arthroplasty.
Frequently asked questions
What makes the iTotal Cruciate Retaining Knee Replacement System different from standard knee implants in terms of how it preserves knee function?
The iTotal system is designed to retain the anterior cruciate ligament (ACL) while replacing the knee joint, unlike some other implants that may sacrifice it. Its key innovation is patient-specific, computer-assisted design, which tailors the prosthesis to the individual’s anatomy. This approach aims to restore natural knee mechanics, reduce overhang or under-coverage, and improve alignment compared to traditional one-size-fits-all implants.
Is the iTotal Cruciate Retaining Knee Replacement System reusable, or is it intended for single-use only?
The iTotal system is explicitly supplied as a sterile, single-use implant. This design ensures patient safety by preventing cross-contamination and maintains aseptic conditions during orthopedic surgery, where reuse could introduce risks.
Can this knee implant be used with MRI machines, and why is that important for patients?
Yes, the iTotal Cruciate Retaining Knee Replacement System is MRI-safe, which is critical for patients who may need follow-up imaging. MRI compatibility allows for non-invasive monitoring of the implant and surrounding tissues without the need for alternative imaging modalities, reducing exposure to radiation or other potential risks.
How is the iTotal system customized to fit patients, and what benefits does this personalization offer?
The iTotal system uses patient-specific, computer-assisted design to create custom-fit configurations for each implant. This personalization minimizes issues like overhang or under-coverage, which can affect stability, comfort, and long-term outcomes. By matching the prosthesis to the patient’s unique anatomy, it aims to improve alignment and restore more natural knee function.
What kind of surgical setting is required for the implantation of the iTotal Cruciate Retaining Knee Replacement System?
The system is intended for use in orthopedic surgical settings where aseptic conditions can be maintained. Since it is sterile and single-use, the operating environment must adhere to strict protocols to prevent contamination, ensuring patient safety during the procedure.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: iTotal CR | Surgeon Resource Center | Conformis, Our Products - Conformis, Full Knee Replacement | iTotal CR - Conformis, Conformis Itotal Cruciate Retaining (Cr) Knee Replacement System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131019 | Class II | Active |
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Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA 510(k) K131019 24 fields · synced Sep 19, 2026