(945 days)
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No
The description focuses on mechanical modifications and materials of a knee implant, with no mention of AI or ML.
No
The device is a knee implant designed to replace part of the knee joint, which falls under the category of a medical device used for surgery.
No
The device description indicates it is a surgical implant (tibial baseplates, patella) used in total knee replacement, not a tool for diagnosing medical conditions.
No
The device description clearly details physical components (tibial baseplates, patella) made of materials like titanium, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant used in knee replacement surgery. It is a physical component (tibial baseplates and patella) designed to be implanted into the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
The device described is a medical device, specifically a prosthetic implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Natural-Knee® Tibial Baseplates involve modifications to the original Natural-Knee® Tibial Baseplates. The modifications to the tibial resurfacing and stemmed baseplates involve the addition of a centrally located screw hole for optional enhanced insert/baseplate fixation. Furthermore, changes to the configuration of the porous coating pockets and increase in overall baseplate thickness were made to the resurfacing baseplate. The Natural-Knee® Baseplates are semi-constrained in design and both the medial and lateral ligaments must be intact. The tibial baseplates are part of the present Natural-Knee® System and mate with the same Natural-Knee® tibial inserts as the existing Natural-Knee® tibial baseplates. The inferior surface of the porous-coated baseplate is coated with Cancellous Structured Titanium (CSTi™).
The Natural-Knee All Poly Patella is designed to articulate with the Natural-Knee® Primary and Revision femoral components. It has a circular shape and is provided in 4 sizes and thicknesses of 7 and 10mm.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of an analysis indicated that the baseplate would withstand acceptable cantilever fatigue loading conditions.
Patello-femoral contact area and lateral subluxation tests were performed. The results of these tests are comparable to competitive all poly patellas.
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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
KY34645
5100k) SUMMARY OF SAFETY AND EFFECTIVENESS MAY - 2 1996
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Natural-Knee Tibial Baseplates and the Natural-Knee All Poly Patella.
| Submitter: | Intermedics Orthopedics", Inc.
1300 East Anderson Lane
Austin, Texas 78752
(512) 835-1971 |
|----------------------|----------------------------------------------------------------------------------------------------|
| Date: | September 29, 1993 |
| Contact Person: | JoAnn Ringer
Manager, Regulatory Affairs |
| Classification Name: | Knee Joint Patellofemorotibial
Polymer/Metal/Polymer Semi-Constrained
Prostheses |
| Common/Usual Name: | Total Knee Replacement, Tibial Articulating
Surface |
| Trade/Proprietary: | Natural-Knee Tibial Baseplates
Natural-Knee• All Poly Patella |
PRODUCT DESCRIPTION/SUBSTANTIAL EQUIVALENCE:
Tibial Components
The Natural-Knee® Tibial Baseplates involve modifications to the original Natural-Knee® Tibial Baseplates. The modifications to the tibial resurfacing and stemmed baseplates involve the addition of a centrally located screw hole for optional enhanced insert/baseplate fixation. Furthermore, changes to the configuration of the porous coating pockets and increase in overall baseplate thickness were made to the resurfacing baseplate. The Natural-Knee® Baseplates are semi-constrained in design and both the medial and lateral ligaments must be intact. The tibial baseplates are part of the present Natural-Knee® System and mate with the same Natural-Knee® tibial inserts as the existing Natural-Knee® tibial baseplates. The inferior surface of the porous-coated baseplate is coated with Cancellous Structured Titanium (CSTi™).
The design is substantially equivalent to the tibial baseplates used in the Kirschner™ Performance™ Knee and the Biomet AGC Knee in that both of the baseplates have centrally located screw holes for tibial tray fixation. The tibial plateau is cruciate retaining as is the Howmedica P.C.A. and the Zimmer Miller-Galante Knee System.
1
Results of an analysis indicated that the baseplate would withstand acceptable cantilever fatigue loading conditions.
Patella
The Natural-Knee All Poly Patella is designed to articulate with the Natural-Knee® Primary and Revision femoral components. It has a circular shape and is provided in 4 sizes and thicknesses of 7 and 10mm. The design is similar to the Richards® Genesis Knee All-Poly Patellae.
Patello-femoral contact area and lateral subluxation tests were performed. The results of these tests are comparable to competitive all poly patellas.