(365 days)
Not Found
Not Found
No
The summary describes a mechanical knee implant made of UHMWPE with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is described as reducing or relieving pain and restoring function and motion to the knee joint, which aligns with the definition of a therapeutic device.
No
The device description indicates its purpose is to reduce or relieve pain and restore function and motion, and it is made of molded polyethylene for the knee joint. This describes a therapeutic device (a knee implant), not one that diagnoses conditions.
No
The device description clearly states it is made of molded ultra-high molecular-weight polyethylene (UHMWPE) and describes physical components like articular surfaces and tibial plates, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce or relieve pain and restore function and motion to the knee joint." This describes a therapeutic intervention performed on the patient's body, not a test performed on a sample taken from the patient's body to diagnose a condition.
- Device Description: The device is a "Complete Knee Solution" made of UHMWPE, designed to be implanted into the knee joint. This is a medical device used for treatment, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside that definition.
N/A
Intended Use / Indications for Use
The device is intended to reduce or relieve pain and restore function and motion to the knee joint.
Product codes
Not Found
Device Description
The NexGen™ Complete Knee Solution, 9 mm articular surfaces are made of molded ultra-high molecular-weight polyethylene (UHMWPE). As with the MG II Knee, each articular surface is snapped into one of a series of the NexGen Knee tibial plates. The components are curved in both the frontal and sagittal planes. The posterior stabilized version having slightly more curvature in the anterior portion of the sagittal plane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Numerous studies reported in the literature for the predicate devices indicate that satisfactory results have been obtained through the use of 9 mm tibial articular surfaces.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MG II® Total Knee System, Insall/Burstein® II Modular Knee System
Reference Device(s)
Not Found
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
MAR 15 1996
KAS 1181
zimmer
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness NexGen™ Complete Knee Solution, 9 mm Tibial Articular Surfaces
This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.
-
Submitted by: .
Zimmer, Inc. 345 East Main Street P.O. Box 708 Warsaw, Indiana 46581-0708 -
Prepared by:
Ruth Ann Wood Regulatory Affairs Associate -
Date: .
March 15, 1995 -
Trade Name: •
NexGen™ Total Knee Solution 9 mm Tibial Articular Surface -
Classification Name: .
Knee joint patellofemorotibial polyethylene/metal/polyethylene semiconstrained cemented prosthesis 21 CFR 888.3560. -
. Identification of the Predicate Device:
MG II® Total Knee System and Insall/Burstein® II Modular Knee System -
. Summary Description:
The NexGen™ Complete Knee Solution, 9 mm articular surfaces are made of molded ultra-high molecular-weight polyethylene (UHMWPE). As with the MG II Knee, each
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A Bristol-Myers Squibb Company
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articular surface is snapped into one of a series of the NexGen Knee tibial plates. The components are curved in both the frontal and sagittal planes. The posterior stabilized version having slightly more curvature in the anterior portion of the sagittal plane.
-
Summary of Intended Uses: .
The device is intended to reduce or relieve pain and restore function and motion to the knee joint. -
Comparison to the Predicate Device:
The 9 mm tibial articular surfaces have the same basic geometric shape, intended use and material as the predicate device. -
. Clinical and Nonclinical Data:
Numerous studies reported in the literature for the predicate devices indicate that satisfactory results have been obtained through the use of 9 mm tibial articular surfaces.
RA03501K.RP