(189 days)
Not Found
No
The document describes a knee prosthesis and its intended use, focusing on material and fixation methods. There is no mention of AI or ML in the device description, intended use, or performance studies. The submission is for an uncemented indication for a device previously cleared for cemented use, indicating a focus on mechanical properties rather than algorithmic capabilities.
Yes
The device is a knee prosthesis, which is implanted to treat severe knee pain and disability, indicating its use in managing a disease or condition for therapeutic purposes.
No
This device is a total knee prosthesis, which is a surgical implant used to replace components of the knee joint. Its intended use is treatment for severe knee pain and disability, not diagnosis.
No
The device description clearly states it is a total knee prosthesis, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens 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 prosthesis, which is an implantable medical device used to replace a damaged knee joint.
- Intended Use: The intended use clearly states it's for patients with severe knee pain and disability due to various conditions, and it describes the surgical implantation of the device.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
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.
CR, LPS and CR-Flex porous coated femoral or tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate and allpolyethylene patella components (including HA/TCP coated) are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
MBH
Device Description
This submission is for the uncemented use of NexGen porous total knee prostheses. All have already been cleared for cemented use.
Porous NexGen Cruciate Retaining (CR) Femoral Components
Porous NexGen CR 4-pegged Tibial Baseplate Components
Porous NexGen Stemmed Tibial Baseplate -Components
Porous NexGen CR-Flex Femoral -Components
Porous NexGen Legacy® Posterior Stabilized (LPS) Femoral Components
Each of the above devices is part of a semiconstrained, non-linked condylar knee system. The CR devices are for use with a functional posterior cruciate ligament and the LPS device is for use with both cruciate ligaments excised.
These devices are identical to the predicate devices except for the uncemented indication for use.
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: No additional testing was required.
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
OCT - 9 2003
长 031061
p.1/2
Summary of Safety and Effectiveness
| 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: | June 30, 2003 |
| Trade Name: | NexGen ® Porous, Uncemented Femoral and Tibial
Baseplate Components |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis - 21 CFR §
888.3565 |
| Predicate Devices: | NexGen Complete Knee Solution, manufactured by
Zimmer, K933785, cleared January 30, 1995. |
| | NexGen Complete Knee Solution Cruciate Retaining
Flex Femoral Component, manufactured by
Zimmer, K023211, cleared October 17, 2002. |
| | NexGen Complete Knee Solution Legacy Posterior
Stabilized (PS) and Constrained Condylar Knee
(CCK) Femoral Components and Articular Surfaces,
manufactured by Zimmer, K960279, cleared April
26, 1996. |
| Device Description: | This submission is for the uncemented use of
NexGen porous total knee prostheses. All have
already been cleared for cemented use. |
| | Porous NexGen Cruciate Retaining (CR)
Femoral Components
Porous NexGen CR 4-pegged Tibial Baseplate
Components |
1
Image /page/1/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K', '0', '3', '1', '0', '6', and '1'. The characters are written in a simple, handwritten style.
P.2/2
- Porous NexGen Stemmed Tibial Baseplate -Components
- Porous NexGen CR-Flex Femoral -Components
- Porous NexGen Legacy® Posterior Stabilized ﯩﺮ (LPS) Femoral Components
Each of the above devices is part of a semiconstrained, non-linked condylar knee system. The CR devices are for use with a functional posterior cruciate ligament and the LPS device is for use with both cruciate ligaments excised.
These devices are 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. 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.
CR, LPS and CR-Flex porous coated femoral or tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate and all-polyethylene patella components (including HA/TCP coated) are indicated for cemented use only
These devices are identical to the predicate devices except for the uncemented indication for use.
Non-Clinical Performance and Conclusions:
No additional testing was required.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
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 image of an eagle or bird-like figure with three stylized lines representing its wings or body.
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: K031061
Trade/Device Name: NexGen® Porous, Uncemented Femoral and Tibial Baseplate Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: July 16, 2003 Received: July 17, 2003
OCT - 9 2003
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 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 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.
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), please contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
b. Mark N. Millenson
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
K031061 510(k) Number (if known):
Device Name:
NexGen® Porous, Uncemented Femoral and Tibial Baseplate 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. .
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral ー 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.
CR, LPS and CR-Flex porous coated femoral or tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate and allpolyethylene patella components (including HA/TCP coated) are indicated for cemented use only .
(Please do not write below this line - Continue on another page if nooded)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
for Mula N. Millen
(Division Sig
. Restorative ovices
510(k) Number_
000012