(280 days)
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No
The description focuses on the material, design, and physical characteristics of a knee implant component, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a knee implant indicated for conditions like arthritis and failed replacements, which are chronic medical conditions requiring therapeutic intervention.
No
Explanation: The device is a knee replacement component, specifically a tibial component, used for orthopedic procedures. Its function is to replace damaged or diseased knee components, not to diagnose medical conditions.
No
The device description clearly states it is a physical component manufactured from ultra-high molecular weight polyethylene with titanium X-Ray markers, indicating it is a hardware device.
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 due to various forms of arthritis or failed previous surgeries. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a physical implant made of polyethylene and titanium markers, designed to be surgically implanted into the tibia.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to replace a damaged body part.
N/A
Intended Use / Indications for Use
The Consensus® All Poly Tibia is indicated for use in:
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- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
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- Failed osteotomy or unicompartmental replacements
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- Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
Product codes
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Device Description
The Consensus® Knee All Poly Tibia component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is a symmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for macro-cement interdigitation between the implant and the bone. Each component has two titanium X-Ray markers for postoperative evaluation: one placed vertically in the distal end of the stem, and one placed horizontally in the central anterior aspect of the component. The design is available in six sizes and each size is available in five thicknesses. The minimum thickness of polyethylene under the articulating surface is 7.5mm for all sizes. The Consensus® All Poly Tibia will be provided sterile.
The Consensus® All Poly Tibia is designed for use with the following Consensus® Total Knee System components:
Consensus® Nonporous CoCr Femoral component
Consensus® Porous CoCr Femoral Component
Consensus® Patellar component. All Polyethylene
Consensus® Patellar component, Titanium/Polyethylene
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: The device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Conclusions from Non-clinical and Clinical Data: The Consensus® All Poly Tibia is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
0
APR - 1 1963
ATTACHMENT 8 amended 17 Oct 1995
Summary of Safety and Effectiveness
510(k) SUMMARY
US MEDICAL PRODUCTS, INC. CONSENSUS® KNEE ALL POLY TIBIA
US Medical Products, Inc. 12201 Technology Boulevard Suite 100 Austin, Texas 78727
William N. Thompson, Director Quality Assurance and Regulatory Affairs Voice (512) 257-4835 Fax (512) 257-8300 Date of Preparation 17 Oct 1995
Trade Name: Consensus® All Poly Tibia
Common Name: All Poly (UHMWPE) tibial baseplate knee prosthesis
Classification Name: Prosthesis, knee, patello/femorotibial, semi-constrained, cemented, polymer/metal/polymer, under classification 21CFR888.3560.
Substantial Equivalence: equivalent All poly tibia components are as follows:
| Howmedica Duracon All Plastic Tibial component K922048 | SE Sep 8, 1992 | |
|---|---|---|
| Intermedics Orthopedics All-Poly Tibia | K923443 | SE 3-31-93 |
| Johnson&Johnson PFC All Plastic Tibia | K910563 | SE 5-23-91 |
Device Description: The Consensus® Knee All Poly Tibia component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is a symmetric cruciateretaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for macro-cement interdigitation between the implant and the bone. Each component has two titanium X-Ray markers for postoperative evaluation: one placed vertically in the distal end of the stem, and one placed horizontally in the central anterior aspect of the component. The design is available in six sizes and each size is available in five thicknesses. The minimum thickness of polyethylene under the articulating surface is 7.5mm for all sizes. The Consensus® All Poly Tibia will be provided sterile.
1
The Consensus® All Poly Tibia is designed for use with the following Consensus® Total Knee System components:
Consensus® Nonporous CoCr Femoral component Consensus® Porous CoCr Femoral Component Consensus® Patellar component. All Polyethylene Consensus® Patellar component, Titanium/Polyethylene
Intended Use: The Consensus® All Poly Tibia is indicated for use in:
-
- Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
-
- Failed osteotomy or unicompartmental replacements
-
- Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
Summary of Technological Characteristics: The Consensus® All Poly Tibia is a symmetric UHMWPE cruciate-retaining tibial component designed to articulate with the Consensus® Knee primary femoral component. The inferior surface employs dovetail grooves for macro cement interdigitation. Each component has two titanium X-Ray markers, and is available in six sizes, each in five thicknesses, minimum 7.5mm articulating surface thickness.
Performance Data: The device performs with substantial equivalence to predicate devices.
Clinical Data: None Required
Conclusions from Non-clinical and Clinical Data: substantially equivalent to predicate devices.
The Consensus® All Poly Tibia is
Other Necessary Information: None Required