(136 days)
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No
The document describes a mechanical implant (tibial insert) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for patients with conditions such as arthritis and failed knee replacements to provide stability and improve function, which are therapeutic aims.
No
The device description and intended use indicate that the Profix Plus Tibial Insert is a component of a knee replacement system used for treatment of arthritis and failed surgeries, not for diagnosing medical conditions.
No
The device description clearly identifies the device as a "Tibial Insert," which is a physical component of a knee replacement system. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a "Profix Plus Tibial Insert," which is a component of a knee replacement system. This is an implantable device used within the body during surgery.
- Intended Use: The intended use describes the conditions for which the knee replacement system is used (arthritis, failed surgeries, etc.). This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Profix Plus Tibial Insert when used with the Profix Knee System is designed for patients with the following indications:
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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.
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- Constrained Systems are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
The Profix Plus Tibial Insert is also indicated for use where a knee cannot be stabilized by soft tissue release. The Profix Plus Tibial Insert is part of a system that is indicated for use only with cement and is a single use device.
- Constrained Systems are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
Product codes
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Device Description
The Profix Plus Tibial insert is designed to work with the Profix Knee System to provide for the option of rotational constraint. The tibial insert is a single use device. The Profix Knee System is for Cemented use only.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
older patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
This device has been tested and produced acceptable results that indicate that the product should perform well.
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
EXHIBIT 4
12963255
Summary of Safety and Effectiveness
Smith & Nephew Orthopaedics
JAN - 2 1997
Profix Plus Tibial Insert
The Profix Plus Tibial insert is designed to work with the Profix Knee System to provide for the option of rotational constraint. The tibial insert is a single use device. The Profix Knee System is for Cemented use only.
The Profix Plus Tibial Insert when used with the Profix Knee System is designed for patients with the following indications:
-
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.
-
- Constrained Systems are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
The Profix Plus Tibial Insert is also indicated for use where a knee cannot be stabilized by soft tissue release. The Profix Plus Tibial Insert is part of a system that is indicated for use only with cement and is a single use device.
- Constrained Systems are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
This device has been tested and produced acceptable results that indicate that the product should perform well.