(30 days)
The NexGen® Primary Porous Patellar components are intended as a patellar component whose indications for use include: 1) Non-inflammatory degenerative disease joint including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, and 5) treatment of that are unmanageable using other fractures techniques. This device is intended for use with bone cement.
The NexGen Primary Porous Patella is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct ultra-high molecular weight compression molded polyethylene (UHMWPE). The Primary Porous Patella is available in two options: 'Micro and Standard. These patellar components are intended for use with Zimmer NexGen Femoral components.
This document is a 510(k) Premarket Notification for the NexGen® Primary Porous Patella and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
It is a regulatory submission demonstrating the device's substantial equivalence to existing legally marketed devices, rather than a clinical study report. Therefore, I cannot extract the requested information from the provided text.
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JUL 1 9 2001
Implex Corp.
KO11904
NexGen® Primary Porous Patella 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The NexGen® Primary Porous Patella
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person: | Robert Poggie |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 995-9722 |
| Date Prepared: | June 11, 2001 |
| Device Trade Name: | The NexGen Primary Porous Patella |
| Device CommonName: | Patellar Components |
| Classification Numberand Name: | 21 CFR § 888.3560 |
The term "substantial equivalence" as used in this Substantial 510(k) notification is limited to the definition of Equivalence: substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or determination of substantial র্ব reclassification. equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
The NexGen Primary Porous Patella is manufactured from Device Description: Trabecular Metal (Hedrocel Porous Tantalum) with direct ultra-high molecular weight compression molded polyethylene (UHMWPE). The Primary Porous Patella is available in two options: 'Micro and Standard.
These patellar components are intended for use with Zimmer NexGen Femoral components.
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510(k) Summary (Continued)
Indications for Use:
The NexGen® Primary Porous Patellar components are intended as a patellar component whose indications for use include:
- Non-inflammatory degenerative disease joint including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, and 5) treatment of that are unmanageable using other fractures techniques. This device is intended for use with bone cement.
Conclusion:
The NexGen® Primary Porous Patella (Micro and Standard) is substantially equivalent to the identified predicate devices.
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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
JUL 1 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K011904
Trade Name: Nexgen® Primary Porous Patella Regulation Number: 21 CFR 888.3560 Regulatory Class: II Product Code: JWH Dated: June 18, 2001 Received: June 19, 2001
Dear Dr. Poggie:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becaon 9 rQx) nextreatially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, if s stated in the encreasure) to device Amendments, or to devices that have been reclassified in ellacinem uate of the Medical Doviet Falleral Food, Drug, and Cosmetic Act (Act). You may, accordance with the provisions of the redereral controls provisions of the Act. The general therefore, market the device, subject to expect to annual registration, listing of devices, controls provisions or the receiners and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see asono) and additional controls. Existing major regulations (Premarket Apploval), it may of success of Federal Regulations, Title 21, Parts 800 to 895. alleoting your as not not valent determination assumes compliance with the current Good A Substantaliy equirvalent decemmant, as set forth in the Quality System Regulation (QS) for Manufacturing Praction regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, are rood and Drag result in regulatory action. In addition, FDA may publish comply with the GMI Togatation may redevice in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might It spollse to your promative no anounces ander the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Robert A. Poggie, Ph.D.
This letter will allow you to begin marketing your device as described in your of 11 kl.) premarket This letter will anow you to begin manoung your device to a legally marketed notification. The FDA imania of substantal equiveland 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 II you desire specific articles your do novelopments the Office of Compliance at additionally 809.10 for m Vitto diagnoution and advertising of your device, (301) 594-4039. Addinonally, for questions on as p-4639. Also, please note the regulation please contact the Office or Comphanee as (2011) 11:11 807.97). Other general entitled, TMIsoranuming by relevelov peember 1999 be obtained from the Division of Small
information on your responsibilities under the Act 1991) 142, 6697, and its information on your responsionnites under (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
NMMKLLLLLLTM
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
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Implex Corp.
510(k) Number (if known) :
KOII904
Device Name:
The NexGen® Primary Porous Patella
Indications For Use:
The NexGen® Primary Porous Patella is intended as the patellar component whose indications for use include:
- Non-inflammatory degenerative joint disease including osteoarthritis of traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, traumatic artimus, 2) medinatora annual of the treatments or devices and 5) 4) fevision procedures whole other treatments of ther techniques. This device is intended for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH; Office of Device Evaluation (ODE)
510(k)
Dont dwell too much
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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.