(184 days)
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No
The device description focuses on the mechanical design and material of a knee implant, with no mention of AI or ML capabilities.
Yes
The device is a knee femoral component for total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint to improve function and reduce pain, thus serving a therapeutic purpose.
No
This device is a knee femoral component intended for implantation during total knee arthroplasty, which is a surgical treatment for knee conditions. It is not designed to diagnose any condition.
No
The device description clearly indicates it is a physical implant made of forged Tivanium® Ti-6Al-4V Alloy, intended for surgical implantation in the human knee. It describes physical features like stems, flutes, and locking mechanisms, which are hardware components, 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 implant used in vivo (within the body).
- Device Description: The description details a physical implant made of metal, designed to be surgically placed in the knee joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo surgical implant.
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 proposed fluted, stemmed tibials are made of forged Tivanium® Ti-6Al-4V Alloy. Like the tibials, NexGen® Complete Knee Solution, the fluted stemmed tibials cover a multitude of patient specific needs by mating with the NexGen Knee CR, CRA, PS, L-PS and L-CCK articular surfaces. The proposed fluted stemmed tibial component shares many features with the NexGen Knee stemmed tibials discussed above. It is the same in these respects: - Length of the stem . - Angle of the stem relative to the distal plate surface . - Position of the cylindrical portion of the stem in the anterior/posterior direction . - Stem extension locking taper design . - Articular surface locking mechanism . - Minimum taper wall thickness . - . Depth of the cement mantle pockets in the distal plate surface, size offerings, and material. The primary difference between the proposed fluted stemmed tibial components and the cleared stemmed tibial component involves the stem base shape. The proposed design uses flutes like the Insall/Burstein® Knee predicate design. The stem base shape has a posterior slope similar to the Insall/Burstein Knee. The stem base has a flute on both the lateral and medial edges which provide channels to direct cement flow from the distal tip to the proximal surface of the cut tibial during insertion, thus, enhancing cement fixation. These flutes give the implant its name. The cleared stemmed tibial component ribs have been replaced by integral flared supports at the base of the stem.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data was submitted in the 510(k) for fatigue strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
NexGen® Complete Knee Solution, Insall/Burstein® Total Knee System
Reference Device(s)
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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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a stylized letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font.
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness
EB | 3 |997
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, Indiana 46581-0708 -
Prepared by: .
Ruth Ann Wood Senior Regulatory Affairs Associate -
. Date:
August 12, 1996 -
Trade Name: .
NexGen® Complete Knee Solution Fluted Stemmed Tibial Component -
Classification: .
Class II 21 CFR 888.3530 -
Predicate Devices: .
NexGen® Complete Knee Solution and the Insall/Burstein® Total Knee System -
Device Description: .
The proposed fluted, stemmed tibials are made of forged Tivanium® Ti-6Al-4V Alloy. Like the tibials, NexGen® Complete Knee Solution, the fluted stemmed tibials cover a multitude of patient specific needs by mating with the NexGen Knee
Image /page/0/Picture/21 description: The image shows a geometric design. The design is composed of six identical shapes arranged in a circular pattern around a central point. Each shape is a hexagon divided into six equilateral triangles, with the triangles pointing towards the center of the hexagon.
1
CR, CRA, PS, L-PS and L-CCK articular surfaces. The proposed fluted stemmed tibial component shares many features with the NexGen Knee stemmed tibials discussed above. It is the same in these respects:
- Length of the stem .
- Angle of the stem relative to the distal plate surface .
- Position of the cylindrical portion of the stem in the anterior/posterior direction .
- Stem extension locking taper design .
- Articular surface locking mechanism .
- Minimum taper wall thickness .
- . Depth of the cement mantle pockets in the distal plate surface, size offerings, and material.
The primary difference between the proposed fluted stemmed tibial components and the cleared stemmed tibial component involves the stem base shape. The proposed design uses flutes like the Insall/Burstein® Knee predicate design. The stem base shape has a posterior slope similar to the Insall/Burstein Knee. The stem base has a flute on both the lateral and medial edges which provide channels to direct cement flow from the distal tip to the proximal surface of the cut tibial during insertion, thus, enhancing cement fixation. These flutes give the implant its name. The cleared stemmed tibial component ribs have been replaced by integral flared supports at the base of the stem.
-
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 was submitted in the 510(k) for fatigue strength.
RA07601K.510
"Insall/Burstein trademark of The Hospital for Special Surgery