(78 days)
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No
The summary describes a physical implant (patella component) and its intended use in knee replacement surgery. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies described are mechanical tests, not algorithmic performance evaluations.
Yes
The device is a knee replacement component, which is a type of implant used to restore joint function and alleviate pain, classifying it as a therapeutic device.
No
The device is described as a replacement for the articular surface of the patella, indicating it is a prosthetic implant, not a tool for diagnosis.
No
The device description clearly states it is an "all-polyethylene concentric dome patella," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a component of a total knee system for the replacement of the articular surface of the patella. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description reinforces that it's a physical component for knee replacement surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic testing, or any of the typical functions of an IVD.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device, an all-polyethylene concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II 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 concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II components as a total knee system.
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 shear testing were presented, with a comparison to a legally marketed device.
Key Metrics
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Predicate Device(s)
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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
APPENDIX H
JUL - 5 1996
510(k) SUMMARY
K961482
Device: Duracon® Inset Patella with Central Peg
Common Name: Concentric Dome Patella
Classification Name and Reference: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR 888.3560
Proposed Requlatory Class: Class II
Device Product Code: JWH (OR)
This device, an all-polyethylene concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II 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) Genesis Biconvex Patella (Smith & Nephew Richards); 4) Omnifit All-Polyethylene Patella (Osteonics); 5) Miller-Galante II All-Polyethylene Patella (Zimmer) and 6) Kinematic® II All-Polyethylene 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 shear testing were presented, with a comparison to a legally marketed device.
For information, contact:
Margaret F. Crowe Manager, Requlatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7431 - Phone (201) 507-6870 - Fax