(82 days)
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No
The description focuses on a physical implant (all-polyethylene patella) and its intended use in total knee replacement, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is a replacement for the articular surface of the patella in a total knee system, which is a treatment for joint deterioration or damage.
No
This device is an all-polyethylene patella intended for use as a component in a total knee system for the replacement of the articular surface of the patella. It is a prosthetic implant, not a diagnostic tool.
No
The device description clearly states it is an "all-polyethylene patella," which is a physical implant, 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 an "all-polyethylene patella," which is a physical implant intended for surgical replacement of a part of the knee joint.
- Intended Use: The intended use is to be used as a component in a total knee replacement system, surgically implanted into the body.
This device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
This device, an all-polyethylene patella, is intended to be used with the Duracon® femoral and tibial components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.
Product codes
JWH
Device Description
This device, an all-polyethylene patella, is intended to be used with the Duracon® femoral and tibial components as a total knee system. All of the devices are fabricated from Ultra-High Molecular Weight Polyethylene which conforms to ASTM Specification F 648. All of the named components have the same intended use. All of the named devices are implanted using bone cement.
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
patella
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
Patello-femoral contact area and lateral stability testing were presented.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
- Duracon® Recessed Patella (Howmedica); 2) Duracon® All-Poly Patella (Howmedica); 3) Duracon® Metal-Backed Patella (Howmedica) and 4) Kinemax® All Plastic Patella (Howmedica).
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
JUL 9 1996
Device: Duracon® All Polyethylene Patella II
Common Name: All Polyethylene Patella
Classification Name and Reference: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR 888.3560
Proposed Regulatory Class: Class II
Device Product Code: JWH (OR)
This device, an all-polyethylene patella, is intended to be used with the Duracon® femoral and tibial components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.
This patella component is similar in intended use, material, design and operational principles to other legally marketed devices. These devices include: 1) Duracon® Recessed Patella (Howmedica); 2) Duracon® All-Poly Patella (Howmedica); 3) Duracon® Metal-Backed Patella (Howmedica) and 4) Kinemax® All Plastic Patella (Howmedica).
All of the devices are fabricated from Ultra-High Molecular Weight Polyethylene which conforms to ASTM Specification F 648. All of the named components have the same intended use. All of the named devices are implanted using bone cement.
Patello-femoral contact area and lateral stability testing were presented.
For information, contact:
Margaret F. Crowe Manager, Requlatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7431 (201) 507-6870 Fax: