(157 days)
K96 2557
K96 2557
No
The document describes a knee implant system and its mechanical properties, with no mention of AI or ML technology.
Yes
The device is a Genesis II and Profix Knee System, indicated for treating various forms of arthritis and failed knee replacements. As a medical device implanted to alleviate or treat these conditions, it directly contributes to therapy.
No
The device is a knee replacement system used to treat arthritis and failed surgical procedures, not to diagnose a condition.
No
The device description clearly states it is a "Femoral Component," which is a physical implant used in knee replacement surgery, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a knee replacement system used to treat various forms of arthritis and failed previous surgeries. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details a femoral component (part of the knee implant) made of zirconium. This is a physical device implanted in the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro testing.
The device is a surgical implant used for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Genesis II and Profix Knee Systems are indicated for:
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- Rheumatoid arthritis.
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- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
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- Failed osteotomies, unicompartmental replacement, or total knee replacement.
Genesis II and Profix Knee Systems are indicated for use only with cement and are single use devices.
Product codes
Not Found
Device Description
The Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are cruciate retaining components indicated for use with existing Genesis II and Profix System Components. Both are manufactured in a variety of sizes in both left and right orientations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
older patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing was performed according to the requirements in the knee draft guidance document. Testing was also performed to characterize the material properties. All of the test results indicate that both the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are capable of withstanding in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K96 2557
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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K96 2557
Summary of Safety and Effectiveness Smith & Nephew Orthopaedics Genesis II Zirconium Femoral Component Profix Zirconium Femoral Component
Substantial Equivalent Information
The Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are similar to the devices listed below.
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- Genesis II C/R and LDK Femoral Component
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- Profix C/R Femoral Component
- Genesis I C/R Femoral Component 3.
The devices listed above are similar in design to the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component. The zirconium alloy material used to manufacture the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component is the same material used for both the Zirconium Alloy Femoral Head and the Zirconium Alloy Uni-Polar Head.
Device Description
The Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are cruciate retaining components indicated for use with existing Genesis II and Profix System Components. Both are manufactured in a variety of sizes in both left and right orientations.
Indications for Use
Genesis II and Profix Knee Systems are indicated for:
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
Genesis II and Profix Knee Systems are indicated for use only with cement and are single use devices.
Preclinical Testing
Mechanical testing was performed according to the requirements in the knee draft guidance document. Testing was also performed to characterize the material properties. All of the test results indicate that both the Genesis II Zirconium Femoral Component and the Profix Zirconium Femoral Component are capable of withstanding in vivo loading without failure.
JG06246B/19