(78 days)
Cobalt-Chromium Molybdenum Alloy Femoral Heads with Co-Nidium Surface Hardening Process; MG II® Total Knee System with Ti-Nidium® Surface Hardening Process; MG II® Porous Total Knee System, NexGen® Complete Knee Solution; and the Legacy™ Knee System
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No
The summary describes a mechanical knee implant made of metal alloys with different designs and surface treatments. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance study focuses on wear resistance, a mechanical property.
No
This device is a knee femoral component for total knee arthroplasty, which is an implant to replace a damaged joint, not a device used to treat or cure a disease or condition.
No
This device is a knee femoral component, an implantable prosthetic used in total knee arthroplasty, not a tool for diagnosis. Its purpose is to replace part of the knee joint.
No
The device description clearly states the device is a physical implant made of metal alloy for knee replacement surgery. It describes material composition, manufacturing processes, and physical configurations, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "implanted in the human knee during total knee arthroplasty." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is a physical implant (femoral component) made of metal alloy. IVDs are typically reagents, kits, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is a surgical implant used for structural support and function within the body, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Knee femoral components are single use devices implanted in the human knee during total knee arthroplasty. This knee is intended for cement use only.
Product codes
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Device Description
The femorals are made of cast Zimaloy® Cobalt-Chromium-Molybdenum Alloy. They are hardened by the Co-Nidium™ Surface Hardening Process described in Section XI. They are available in left and right configurations. NexGen/Legacy Knee femorals cover a multitude of patient specific needs with the Cruciate Retaining (CR), Posterior Stabilizing (PS and L-PS), Cruciate Retaining Augmentable (CRA), and Constrained Condylar Knee (L-CCK) designs. Certain femorals can be augmented with stem extensions. The extensions come in a broad variety of straight and offset shapes as well as numerous lengths and diameters. These femorals will be available in precoat, porous, and option (NoCoat) versions.
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
human knee
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
The performance data submitted in the 510(k) demonstrated the improved wear resistance compared to nontreated femoral components.
Key Metrics
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Predicate Device(s)
Cobalt-Chromium Molybdenum Alloy Femoral Heads with Co-Nidium Surface Hardening Process; MG II® Total Knee System with Ti-Nidium® Surface Hardening Process; MG II® Porous Total Knee System, NexGen® Complete Knee Solution; and the Legacy™ Knee System
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
Image /page/0/Picture/0 description: The image shows a date that reads "AUG 23 1996". The month is August, the day is the 23rd, and the year is 1996. The text is written in a simple, sans-serif font. The text is black and the background is white.
Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font. The image is in black and white.
.
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
62196
Summary of Safety and Effectiveness
The summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990.
-
Submitted by:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 -
. Prepared by:
Ruth Ann Wood Senior Regulatory Affairs Associate -
Date: .
June 5, 1996 -
Trade Name: .
NexGen® Complete Knee Solution with Co-Nidium™ Surface Hardening Process and Legacy™ Knee System with Co-Nidium™ Surface Hardening Process -
Classification: .
Class II 21 CFR 888.3530 -
. Predicate Devices:
.
Cobalt-Chromium Molybdenum Alloy Femoral Heads with Co-Nidium Surface Hardening Process; MG II® Total Knee System with Ti-Nidium® Surface Hardening Process; MG II® Porous Total Knee System, NexGen® Complete Knee Solution; and the Legacy™ Knee System Device Description:
The femorals are made of cast Zimaloy® Cobalt-Chromium-Molybdenum Alloy. They are hardened by the Co-Nidium™ Surface Hardening Process described in
Image /page/0/Picture/18 description: The image contains the number 1. The number is black and is set against a white background. The number is tall and thin.
Image /page/0/Picture/19 description: The image shows a logo with a geometric design on the left and the text "A Bristol-Myers" on the right. The geometric design is a hexagon composed of six smaller triangles, each containing an even smaller triangle inside. The text is in a simple, sans-serif font and is aligned horizontally with the geometric design.
1
They are hardened by the Co-Nidium™ Surface Hardening Process described in Section XI. They are available in left and right configurations. NexGen/Legacy Knee femorals cover a multitude of patient specific needs with the Cruciate Retaining (CR), Posterior Stabilizing (PS and L-PS), Cruciate Retaining Augmentable (CRA), and Constrained Condylar Knee (L-CCK) designs. Certain femorals can be augmented with stem extensions. The extensions come in a broad variety of straight and offset shapes as well as numerous lengths and diameters. These femorals will be available in precoat, porous, and option (NoCoat) versions.
-
Intended Use:
Knee femoral components are single use devices implanted in the human knee during total knee arthroplasty. This knee is intended for cement use only. -
Performance Data: .
The performance data submitted in the 510(k) demonstrated the improved wear resistance compared to nontreated femoral components.
RA05603K.510