(41 days)
No
The summary describes a mechanical knee prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a knee prosthesis indicated for patients with severe knee pain and disability due to various conditions, aiming to alleviate symptoms and restore function.
No
This is a knee prosthesis, which is an implant used to replace a damaged joint, not a device used to diagnose a medical condition.
No
The device description explicitly states "The NexGen MIS Modular Tibial Plates and Keels are part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical implantation to treat severe knee pain and disability. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor conditions.
- Device Description: The description refers to "Tibial Plates and Keels" which are components of a knee prosthesis, designed to be implanted into the knee joint.
- Anatomical Site: The anatomical site is the "Knee," which is an internal body part.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
This device is a surgical implant, specifically a knee prosthesis component.
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 ratellofemoral 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
JWH
Device Description
The NexGen MIS Modular Tibial Plates and Keels 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)
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 data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 contains the logo for Zimmer. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a sans-serif font. The logo is black and white.
:
:
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher
Associate, Corporate Regulatory Affairs
Telephone: (574) 371-8083
Fax: (574) 372-4605 |
| Date: | October 11, 2005 |
| Trade Name: | NexGen ® Complete Knee Solution MIS ™ Modular
Tibial Plates and Keels |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint patellofemorotibial polymer/metal/
polymer semi-constrained cemented prosthesis
21 CFR § 888.3560 |
| Predicate Device: | NexGen ® Complete Knee Solution, manufactured
by Zimmer, Inc., K933785, cleared January 30,
1995 |
| Device Description: | The NexGen MIS Modular Tibial Plates and Keels
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,
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 |
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Image /page/1/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside a circle, followed by the word "zimmer" in a bold, sans-serif font. The "Z" is black and white, and the word "zimmer" is black.
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 Modular Tibial Plates and Keels are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is manufactured, packaged and sterilized using the same materials and processes. Performance Data (Nonclinical Non-Clinical Performance and Conclusions: and/or Clinical): 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.
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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 circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2005
Mr. Brandon Hipsher Associate, Corporate Regulatory Affairs Zimmer, Inc. P. O. Box 708 Warsaw, Indiana 46581-0708
Re: K052879
Trade/Device Name: NexGen Complete Knee Solution MIS Modular Tibial Plates and Keels Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: November 03, 2005 Received: November 07, 2005
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Mr. Brandon Hipsher
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Image /page/3/Picture/4 description: The image contains a handwritten symbol or character that resembles a stylized letter 'S' or a cursive 'So'. The symbol is drawn with a continuous stroke, starting with a loop at the top and extending downwards with a curve. The stroke is thicker at the bottom, giving the symbol a sense of weight or emphasis.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Complete Knee Solution MIS™ Modular Tibial Plates and Keels
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 ratellofemoral 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.
Prescription Use _X (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
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510(k) Number K052879