(118 days)
Not Found
No
The document describes a knee prosthesis and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is indicated for severe knee pain and disability due to various medical conditions, aiming to treat or alleviate these conditions.
No
The device is a knee prosthesis, which is an implant used for treatment, not diagnosis. The "Intended Use" section lists conditions for which the device is indicated as a treatment, not for diagnosing those conditions.
No
The device description explicitly states "The NexGen MIS Tibial Components are part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses," indicating 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 describes a device used to treat severe knee pain and disability by replacing parts of the knee joint. This is a surgical implant, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is described as a "semiconstrained, nonlinked condylar knee prostheses," which are components of a knee replacement system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is an in vivo (within the body) implant used for treatment.
N/A
Intended Use / Indications for Use
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The NexGen MIS Tibial Components are part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Non-Clinical Performance and Conclusions:
Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 7 - 2005
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher
Specialist, Corporate Regulatory Affairs
Telephone: (574) 371-8083
Fax: (574) 372-4605 |
| Date: | November 8, 2004 |
| Trade Name: | NexGen ® Complete Knee Solution MIS ™ Tibial
Components |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint patellofemorotibial polymer/metal/
polymer semi-constrained cemented prosthesis
21 CFR § 888.3560 |
| Predicate Devices: | NexGen Precoat Stemmed Tibial Plates and Stem
Extensions, manufactured by Zimmer, Inc.,
K933785, cleared January 30, 1995.
NexGen Locking Screws and Taper Stem Plugs,
manufactured by Zimmer, Inc., K991581, cleared
July 30, 1999.
NexGen Porous, Uncemented Femoral and Tibial
Baseplate Components, manufactured by Zimmer,
Inc., K031061, cleared October 3, 2003. |
| Device Description: | The NexGen MIS Tibial Components are part of the
NexGen system of semiconstrained, nonlinked
condylar knee prostheses. |
| Intended Use: | This device is indicated for patients with severe
knee pain and disability due to:
Rheumatoid arthritis, osteoarthritis,
traumatic arthritis, polyarthritis.Collagen disorders, and/or avascular
necrosis of the femoral condyle.Post-traumatic loss of joint configuration, |
1
K643101
and the comments of the comments of the comments of the comments of
| | particularly when there is patellofemoral
erosion, dysfunction or prior patellectomy
Moderate valgus, varus, or flexion
deformities.
- The salvage of previously failed surgical
attempts or for a knee in which satisfactory
stability in flexion cannot be obtained at the
time of surgery.
This device is intended for cemented use only. |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | Except for minor modifications, MIS Tibial
Components are identical to the predicate devices.
The modifications do not change the intended use o
the fundamental scientific technology. The device
is packaged and sterilized using the same materials
and processes. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Performance testing completed as part of the design
assurance process demonstrated that this device is
safe and effective and substantially equivalent to th
predicate device. |
| | Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for
this device. |
and the same of the same of the same of the same
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
MAR 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brandon Hipsher Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K043101
KU43101
Trade/Device Name: NexGen® Complete Knee Solution MISTM Tibial Components Regulation Number: 21 CFR 888.3560 Regulation Name: Enee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II
Product Code: JWH Dated: February 4, 2005 Received: February 7, 2005
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the device wE have teviewed your bected. 9 10(2) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1776, the excordance with the provisions of the Federal Food, Drug, de necs mat have been reciasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelors, mains of the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassinod (over as controls. Existing major regulations affecting your device can may oc subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 that FDA has made a determination that your device complies with other requirements of the Act that I Drivias intatutes and regulations administered by other Federal agencies. You must of any I caefal statuted and regisments, including, but not limited to: registration and listing (21 econfire with an the Not 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of evense (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Brandon Hipsher
This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to begin marketing your article equivalence of your device to a legally premarket notification. The PDA inding of substantial organism to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your active en other and and the regulation entitled, Colliact the Office of Complance at (210) = 16 = 21 807.97). You may obtain Mission of the release to premantonibilities under the Act from the Division of Small be other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octrise http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Melleman
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K043101
Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Complete Knee Solution MIS™ Tibial Components
Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- evice is indicated for patients withis, traumatic arthritis, polyarthritis.
Rheumatoid arthritis, osteoarthritis, traumatic arthritis, । - Rheumatord artifulis, osteourantials, necrosis of the femoral condyle. -
- Collagen disorders and or avascular necrosis of when there is patellofemoral । erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities. l
- Moderate Valgus, Varas of Trekton ugical attempts or for a knee in which ﺖ I he saivage of previously fance surgious atthe fime of surgery.
This device is intended for cemented use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
710(k) Number
Page 1 of 1
0083