(85 days)
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No
The device description and performance studies focus on the mechanical properties and physical performance of a knee implant, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a knee replacement component intended for the reduction or relief of pain and improved knee function, which are therapeutic outcomes.
No
Explanation: The device described is a knee replacement component (ADVANCE™ Tibial Component), intended for surgical replacement of the knee joint. Its purpose is to repair or restore function, not to diagnose a condition.
No
The device description clearly states it is a modular two-piece component consisting of a metal tibial base and a plastic insert, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the knee joint to treat conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a component of a total knee replacement system, consisting of metal and plastic parts intended for surgical implantation with bone cement. This is a medical device used for treatment, not for diagnostic testing of samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ADVANCE™ Tibial Component does not fit this description.
N/A
Intended Use / Indications for Use
The ADVANCE™ Tibial Component is intended for tricompartmental replacement of the knee for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis: 3) correction of functional deformity: 4) revision procedures where other treatments or devices have failed; 5) treatment of fractures that are unmanageable using other techniques.
Product codes
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Device Description
The ADVANCE™ Tibial Component is part of the ADVANCE™ Total Knee System, a total knee replacement system consisting of femoral, tibial, and patellar components. The ADVANCE™ Tibial Component is a modular two-piece component consisting of a metal tibial base and a plastic insert. The ADVANCE™ Tibial Component is intended to be used only with bone coment.
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
knee
Indicated Patient Age Range
skeletally mature 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
- Submitted fatigue testing demonstrates that the ADVANCE™ Tibial Base Component was able . to withstand test loading designed to simulate in vivo loading.
- Submitted femoral-tibial contact area testing demonstrates that the ADVANCE™ Tibial . Component is more conforming (higher contact area) than independently published data for the predicate device.
- Submitted locking detail testing demonstrates that the ADVANCE™ Tibial Component lock . detail integrity is comparable to other posterior stabilized knee systems available on the market.
- . Submitted femoral-tibial constraint testing (anterior shear, medial shear, lateral shear, and rotation) demonstrates that the ADVANCE™ Tibial Component is expected to remain stable and resist displacement when subjected to appropriate physiological loads.
- Submitted ultra high molecular weight polvethylene (UHMWPE) properties demonstrate that the ADVANCE™ tibial insert polyethylene components should perform adequately.
Key Metrics
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Predicate Device(s)
Insall/Burstein Modular Total Knee System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo consists of a stylized "W" on the left, followed by the company name in bold, uppercase letters. Below the company name is the address "5677 Airline Rd Arlington, TN 38002" and the phone number "901-867-9971".
Contact Person: Judy English Date Prepared: February 12, 1996
510(k) Summary of Safety and Effectiveness
| Trade Name: | ADVANCE™ Tibial Component |
|---|---|
| Common Name: | Metal-backed Tibial Component |
| Product Classification: | II |
| Predicate Device: | Insall/Burstein Modular Total Knee System |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/intended Use
The ADVANCE™ Tibial Component is part of the ADVANCE™ Total Knee System, a total knee replacement system consisting of femoral, tibial, and patellar components. The ADVANCE™ Tibial Component is a modular two-piece component consisting of a metal tibial base and a plastic insert. The ADVANCE™ Tibial Component is intended to be used only with bone coment.
The ADVANCE™ Tibial Component is intended for tricompartmental replacement of the knee for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis: 3) correction of functional deformity: 4) revision procedures where other treatments or devices have failed; 5) treatment of fractures that are unmanageable using other techniques.
Materials
The metallic tibial base component is manufactured from cobalt chrome alloy. The tibial insert components are manufactured from ultra high molecular weight polyethylene.
Testing Summary
- Submitted fatigue testing demonstrates that the ADVANCE™ Tibial Base Component was able . to withstand test loading designed to simulate in vivo loading.
- Submitted femoral-tibial contact area testing demonstrates that the ADVANCE™ Tibial . Component is more conforming (higher contact area) than independently published data for the predicate device.
- Submitted locking detail testing demonstrates that the ADVANCE™ Tibial Component lock . detail integrity is comparable to other posterior stabilized knee systems available on the market.
- . Submitted femoral-tibial constraint testing (anterior shear, medial shear, lateral shear, and rotation) demonstrates that the ADVANCE™ Tibial Component is expected to remain stable and resist displacement when subjected to appropriate physiological loads.
- Submitted ultra high molecular weight polvethylene (UHMWPE) properties demonstrate that the ADVANCE™ tibial insert polyethylene components should perform adequately.
Image /page/0/Picture/18 description: The image shows a sequence of five digits: 00279. The digits are bold and black, standing out against what appears to be a white background. The font is simple and sans-serif, making the numbers easily readable.