(30 days)
No
The summary describes a mechanical implant (total knee replacement components) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device description indicates it is a component of a total knee replacement system, which replaces a diseased or damaged joint. While it aims to alleviate pain and disability, it is not a therapeutic device in the sense of delivering therapy or treatment. It is a prosthetic implant.
No
Explanation: The device is a total knee replacement implant, which is a therapeutic device used in surgical procedures. Its purpose is to treat severe knee pain and disability, not to diagnose a condition.
No
The device description clearly states it is a "Stemmed tibial baseplate component," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a total knee replacement system, specifically components of a stemmed tibial baseplate. This is an implantable device used in surgery to replace a damaged knee joint.
- Intended Use: The intended use clearly states it's for treating severe knee pain and disability due to various conditions, which is achieved through surgical implantation, not laboratory testing of samples.
The description focuses on the physical components of the implant and its surgical application, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
Total knee replacement is indicated for patients suffering from 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. These devices are intended for cemented use only.
Product codes
JWH
Device Description
Stemmed tibial baseplate components are part of the MG II Total Knee System. They incorporate a central stem with available modular stem extensions. There are three versions of stemmed tibial baseplate components: Porous, PMMA Precoat, and Option (non-coated). They are available in the same size range, and are compatible with the same articular surface components, as the predicate device.
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)
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)
MG II Porous Total Knee System, manufactured by Zimmer, Inc., K892800
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 large, stylized "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The font is bold and sans-serif. The logo is black and white.
Special 510(k): Device Modification
で
| APR | 20 | 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: | March 18, 2005 |
| Trade Name: | MG II™ Total Knee System Stemmed Tibial
Baseplate 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 Device: | MG II Porous Total Knee System, manufactured by
Zimmer, Inc., K892800, cleared August 3, 1989 |
| Device Description: | Stemmed tibial baseplate components are part of the
MG II Total Knee System. They incorporate a
central stem with available modular stem
extensions. There are three versions of stemmed
tibial baseplate components: Porous, PMMA
Precoat, and Option (non-coated). They are
available in the same size range, and are compatible
with the same articular surface components, as the
predicate device. |
| Intended Use: | Total knee replacement is indicated for patients
suffering from 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. |
| | These devices are intended for cemented use only. |
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Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, stylized letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The letter "Z" and the word "zimmer" are both in a bold, sans-serif font.
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Comparison to Predicate Device:
Except for minor modifications, MG II Stemmed Tibial Baseplate Components are identical to the predicate device. The modifications do not change the intended use or 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 the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines.
APR 2 0 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: K050723
K050723
Trade/Device Name: MG IJ™ Total Knee System Stemmed Tibial Baseplate Components Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Codes: JWH Dated: March 18, 2005 Received: March 21, 2005
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosed. 976, the enactment date of the Medical Device Amendments, or to conninered province that have been reclance with the provisions of the Federal Food, Drug, devices mat have been recuire a require approval of a premarket approval application (PMA). allu Cosmetic Ac, (110) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mainer of the Act include requirements for annual registration, listing of general condois provisions 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 IT your device is classified (600 as 310) of on the major regulations affecting your device can may be subject to subli duditions, 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 I least of advised that I Drivisounces at your device complies with other requirements of the Act that I DA has made a availations administered by other Federal agencies. You must of any I cacal statutes and regalabents and limited to: registration and listing (21 Comply with an the Her STequirements)01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bycrents (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 510(k) This letter will anow you to begin manceling your and equivalence of your device to a legally premaired notincation: The PPA intelligence 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 If you desire specific advice for your access in the regulation of the regulation entitled, contact the Office of Compilance an (21 ) = (21CFR Part 807.97). You may obtain Misolanding by reference to promanteensbilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, international and Octass http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stepto Rhodes
Miriam Provost, Ph.D.
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/1 description: The image shows the Zimmer company logo. The logo consists of a large, stylized letter "Z" enclosed in a circle, followed by the lowercase word "zimmer". The "Z" is bold and black, while the word "zimmer" is in a simple, sans-serif font.
Indications for Use
510(k) Number (if known):
Device Name:
MG II" Total Knee System Stemmed Tibial Baseplate Components
Indications for Use:
Total knee replacement is indicated for patients suffering from 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.
These devices are intended for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
.
్రాల్య
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)
Stypt Rurds
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_________________________________________________________________________________________________________________________________________________________________