(98 days)
Not Found
Not Found
No
The summary describes a total knee replacement device and its intended use, focusing on traditional surgical methods and predicate devices that rely on bone cement. There are no mentions of AI, ML, image processing, or any data-driven analytical components.
Yes
Explanation: The device is indicated to "reduce or relieve pain and restore function and motion to the knee joint," which are therapeutic outcomes. It is a knee replacement, a surgical intervention aimed at treating severe knee conditions.
No
The device is a total knee replacement, which is a therapeutic device designed to relieve pain and restore function, not to diagnose a condition.
No
The 510(k) summary describes a total knee replacement device, which is a physical implant, not a software-only device. The summary focuses on the intended use for surgical intervention and references predicate devices that are also physical implants.
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" through total knee replacement. This describes a surgical procedure and the function of an implanted device within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The provided information does not mention any such testing.
- Device Description: While the device description is "Not Found," the intended use clearly points to a physical implant for surgical use.
- Lack of IVD-related information: There is no mention of samples, assays, reagents, or any other elements typically associated with IVD devices.
The information provided describes a surgical implant used for total knee replacement.
N/A
Intended Use / Indications for Use
To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities.
Product codes
Not Found
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
The NexGen Legacy Posterior Stabilized Knee equals NexGen Posterior Stabilized and Insall/Burstein II Posterior Stabilized, The NexGen Legacy Constrained Condylar Knee equals NexGen Constrained Condylar Knee, Insall/Burstein® II Modular Knee System, and Insall/Burstein® Constrained Condylar Knee
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
Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a large, stylized letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font. The logo is black and white.
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness NexGen® Complete Knee Solution Legacy Posterior Stabilized (PS) and Constrained Condylar Knee (CCK) Femoral Components and Articular Surfaces
Information is being submitted in accordance with the requirements of SMDA 1990
APR 2 6 1996
-
Submitted by: .
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 -
Prepared by: .
Ruth Ann Wood Regulatory Affairs Associate -
Date: ●
January 18, 1996 -
. Trade Name:
NexGen Legacy PS (L-PS) and NexGen Legacy CCK (L-CCK) -
Classification Name: •
Knee joint femorotibial metal/polymer semiconstrained cemented prosthesis -
Predicate Devices: .
-
The NexGen Legacy Posterior Stabilized Knee equals NexGen Posterior Stabilized and Insall/Burstein II Posterior Stabilized
-
The NexGen Legacy Constrained Condylar Knee equals NexGen Constrained Condylar Knee, Insall/Burstein® II Modular Knee System, and Insall/Burstein® Constrained Condylar Knee
-
Image /page/0/Picture/21 description: The image shows a geometric pattern. The pattern is composed of multiple triangles arranged in a hexagonal shape. The triangles are oriented in different directions, creating a complex and symmetrical design.
1
-
Intended Use: .
To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities. -
Comparison to Predicate Devices: .
See attached chart. -
Clinical and Nonclinical Uses: .
Current methods of implant fixation rely on the use of bone cement. Numerous studies reported in literature indicate satisfactory results have been obtained through use of devices to which substantial equivalence is claimed.
RA10501K.RP