(21 days)
Not Found
No
The document describes a mechanical knee prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for alleviating severe knee pain and disability, and for the salvage of previously failed surgical attempts, which are therapeutic functions.
No
This device is a knee prosthesis, which is an implanted medical device used to replace a damaged knee joint, not to diagnose a condition.
No
The device description clearly states it is a "femoral component," which is a physical implant used in knee replacement surgery. This is a hardware device, 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 surgical implant for treating severe knee pain and disability due to various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a knee prosthesis, which is a physical implant used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the safety and effectiveness of the device as a surgical implant, not on its diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Page 1 of 1
510(k) Number (if known):
Device Name:
NexGen® Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components
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, posttraumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy), and moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.
This device is intended for cemented use only
Specific uses with CR-Flex femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex femoral is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The NexGen CR-Flex femoral components are part of the Zimmer Flex-series of semiconstrained, nonlinked condylar knee prostheses that are designed to have a maximum active flexion of 155 degrees.
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 procedure 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): 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.
NexGen CR knee, K933785, NexGen LPS-Flex knee, K991581
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 logo for Zimmer. The logo consists of a large, bold letter Z inside of a circle on the left. To the right of the circle is the word "zimmer" in a smaller, sans-serif font.
K 3 2- 1 0 ನ್ನ 1 ರಿ 2
Summary of Safety and Effectiveness
| OCT 1 7 2002 | |
|---|---|
| Submitter: | Zimmer, Inc. |
| P.O. Box 708 | |
| Warsaw, IN 46581-0708 | |
| Contact Person: | Stephen H. McKelvey |
| Manager, Regulatory Affairs | |
| Telephone: (574) 372-4944 | |
| Fax: (574) 372-4605 | |
| Date: | September 23, 2002 |
| Trade Name: | NexGen® Complete Knee Solution Cruciate |
| Retaining (CR)-Flex Femoral Components | |
| Common Name: | Total Knee Prosthesis |
| Classification Name | |
| and Reference: | Knee joint patellofemorotibial polyethylene/ |
| metal/polyethylene semiconstrained cemented total | |
| knee prosthesis - 21 CFR § 888.3560 | |
| Predicate Devices: | NexGen CR knee, manufactured by Zimmer, |
| K933785, cleared January 30, 1995 and the NexGen | |
| LPS-Flex knee, manufactured by Zimmer, | |
| K991581, cleared July 30, 1999. | |
| Device Description: | The NexGen CR-Flex femoral components are part |
| of the Zimmer Flex-series of semiconstrained, | |
| nonlinked condylar knee prostheses that are | |
| designed to have a maximum active flexion of 155 | |
| degrees. | |
| 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), and | |
| moderate valgus, varus, or flexion deformities. |
1
Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The "Z" in the circle is black, and the word "zimmer" is also black.
Special 510(k): Device Modification
2 3 2 1 1 2 of 2
- The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.
This device is intended for cemented use only
Specific uses with CR-Flex femorals:
- -Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- -The CR-Flex femoral is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
Except for modifications to allow flexion to 155 degrees, CR-Flex femoral 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):
Comparison to Predicate Device:
Non-Clinical Performance and Conclusions:
Performance testing completed as part of the design assurance procedure 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 stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen H. McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K023211
Trade/Device Name: NexGen® Complete Knee Solution Cruciate Retaining Flex Femoral Component
Regulation Number: 888.3560
Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer, semi-constrained Cemented prosthesis
Regulatory Class: II Product Code: JWH Dated: September 23, 2002 Received: September 26, 2002
Dear Mr. McKelvey:
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 vour 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 anv 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Stephen H. McKelvey
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4649. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Mark N Mikkelsen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Page 1 of 1
510(k) Number (if known):
Device Name:
NexGen® Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components
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, posttraumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy), and moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.
This device is intended for cemented use only
Specific uses with CR-Flex femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex femoral is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ma
n
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number __ K023211
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)