(70 days)
Not Found
No
The summary describes a knee prosthesis and does not mention any AI or ML capabilities.
Yes
The device is a knee prosthesis, which is used to treat severe knee pain and disability caused by various conditions, indicating a therapeutic purpose.
No
Explanation: The device is described as a knee prosthesis, indicated for patients with severe knee pain and disability due to various conditions, and used as part of a cemented or uncemented knee prosthesis. Its function is to replace or assist a joint, not to diagnose a condition.
No
The device description explicitly states it is a "part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses," indicating it is 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 clearly describes a device used in vivo (within the body) for the treatment of severe knee pain and disability. It is a surgical implant.
- Device Description: The description confirms it is a component of a knee prosthesis, which is an implantable device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body to replace a damaged knee joint.
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. l
- 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 indicated for use when the posterior cruciate ligament is absent or deficient.
This device is intended for use as part of a cemented or uncemented knee prosthesis.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
This device is 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:
Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as 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
Image /page/0/Picture/0 description: The image shows the Zimmer logo. The logo consists of a stylized letter "Z" inside a circle, followed by the word "zimmer" in lowercase letters. The logo is in black and white.
Summary of Safety and Effectiveness
| Submitter: | MAY 26 2006
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: | March 16, 2006 |
| Trade Name: | NexGen ® Complete Knee Solution Ultracongruent
(UC-Flex) Fixed Bearing Articular Surface
Component |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint patellofemorotibial polymer/metal/
polymer semi-constrained cemented prosthesis
21 CFR § 888.3560 |
| | Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis
21 CFR § 888.3565 |
| Predicate Device: | Prolong ™ Highly Crosslinked Polyethylene
Cruciate Retaining (CR) Articular Surface
Component, manufactured by Zimmer, Inc.,
K013991, cleared December 27, 2001 |
| Device Description: | This device is 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
Image /page/1/Picture/0 description: The image shows the title "Traditional 510(k) Premarket Notification". The text is in bold font. The title is centered on the page.
particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus or flexion deformities. ﮯ
- 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 indicated for use when the posterior cruciate ligament is absent or deficient. This device is intended for use as part of a cemented or uncemented knee prosthesis.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
The proposed device is manufactured, packaged and sterilized using the same materials and processes as the predicate device.
Non-Clinical Performance and Conclusions:
Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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 circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2006
Zimmer, Inc. % Mr. Brandon Hipsher, RAC Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K060722
Trade/Device Name: NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH, MBH
Dated: March 16, 2006 Received: March 17, 2006
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 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
3
Page 2 - Mr. Brandon Hipsher
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,
Herbert Lerner us
Mark N. Melkerson 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): KO607222
Device Name:
NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component
Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. l
- 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 indicated for use when the posterior cruciate ligament is absent or deficient.
This device is intended for use as part of a cemented or uncemented knee prosthesis.
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)
Helene Lehner
Division of General, Restorative, and Neurological Devices
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510(k) Number K060722
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