(41 days)
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 ratellofemoral 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 intended for cemented use only.
The NexGen MIS Modular Tibial Plates and Keels are part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.
The provided text is a 510(k) summary for the Zimmer NexGen MIS Modular Tibial Plates and Keels. It is a premarket notification for a medical device seeking clearance based on substantial equivalence to a predicate device, not a study reporting on the device's performance against specific acceptance criteria.
Therefore, the document does not contain the information required to populate the requested table about acceptance criteria, device performance, or details about a study proving the device meets those criteria.
Specifically, the document states:
- Performance Data (Nonclinical and/or Clinical): "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."
This indicates that the Zimmer NexGen MIS Modular Tibial Plates and Keels were cleared based on design assurance performance testing and substantial equivalence to a previously cleared predicate device (NexGen Complete Knee Solution, K933785, cleared January 30, 1995), not on clinical studies with specific acceptance criteria as you've requested. The modifications from the predicate device were considered minor and not to change the intended use or fundamental scientific technology.
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Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Brandon HipsherAssociate, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | October 11, 2005 |
| Trade Name: | NexGen ® Complete Knee Solution MIS ™ ModularTibial Plates and Keels |
| Common Name: | Total Knee Prosthesis |
| Classification Nameand Reference: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis21 CFR § 888.3560 |
| Predicate Device: | NexGen ® Complete Knee Solution, manufacturedby Zimmer, Inc., K933785, cleared January 30,1995 |
| Device Description: | The NexGen MIS Modular Tibial Plates and Keelsare part of the NexGen system of semiconstrained,nonlinked condylar knee prostheses. |
| Intended Use: | This device is indicated for patients with severeknee pain and disability due to:- Rheumatoid arthritis, osteoarthritis,traumatic arthritis, polyarthritis.- Collagen disorders, and/or avascularnecrosis of the femoral condyle.- Post-traumatic loss of joint configuration,particularly when there is patellofemoralerosion, dysfunction or prior patellectomy- Moderate valgus, varus, or flexiondeformities.- The salvage of previously failed surgicalattempts or for a knee in which satisfactory |
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stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only. Comparison to Predicate Device: Except for minor modifications, MIS Modular Tibial Plates and Keels are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is manufactured, packaged and sterilized using the same materials and processes. Performance Data (Nonclinical Non-Clinical Performance and Conclusions: and/or Clinical): 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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 2 2005
Mr. Brandon Hipsher Associate, Corporate Regulatory Affairs Zimmer, Inc. P. O. Box 708 Warsaw, Indiana 46581-0708
Re: K052879
Trade/Device Name: NexGen Complete Knee Solution MIS Modular Tibial Plates and Keels Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: November 03, 2005 Received: November 07, 2005
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
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Page 2 - Mr. Brandon Hipsher
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. 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,
Mark N. Melkerson
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Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Complete Knee Solution MIS™ Modular Tibial Plates and Keels
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 ratellofemoral 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 intended for cemented use only.
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K052879
§ 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.