(118 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 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 intended for cemented use only.
The NexGen MIS Tibial Components are part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.
Here's an analysis of the provided FDA 510(k) summary, focusing on the absence of specific acceptance criteria and detailed study information, as is often the case with predicate device submissions.
Acceptance Criteria and Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Not explicitly stated in the provided document (e.g., specific fatigue limits, wear rates, tensile strength, etc.) | "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." |
| Biocompatibility | Not explicitly stated (implied to be met through material equivalence to predicate) | Not explicitly detailed, but implied to be equivalent to predicate due to "same materials and processes." |
| Sterilization | Not explicitly stated (implied to be met through equivalence to predicate) | "The device is packaged and sterilized using the same materials and processes." |
| Material Properties | Not explicitly stated (implied to be met through equivalence to predicate) | "same materials and processes" as predicate devices. |
| Clinical Efficacy/Safety | Not applicable; no clinical acceptance criteria were required. | "Clinical data and conclusions were not needed for this device." |
Explanation: This 510(k) submission for the NexGen® Complete Knee Solution MIS™ Tibial Components relies on substantial equivalence to previously cleared predicate devices (K933785, K991581, K031061). In such cases, detailed, de novo acceptance criteria and performance metrics are typically not provided as they would be for a new device. Instead, the device is deemed acceptable if it can demonstrate equivalent safety and effectiveness to legally marketed predicate devices, usually through non-clinical performance testing that confirms the modifications do not alter the fundamental scientific technology or intended use. The document explicitly states that clinical data was not needed.
Study Information (Based on the Provided Document):
This submission does not describe a clinical study comparing the device to a set acceptance criterion, but rather relies on non-clinical performance testing and substantial equivalence to predicate devices. Therefore, many of the requested categories are not applicable or cannot be determined from the provided text.
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable for a clinical study, as "Clinical data and conclusions were not needed for this device." For non-clinical performance testing, the sample sizes for mechanical tests (e.g., fatigue, static strength) are not specified in this summary.
- Data Provenance: Not applicable for a clinical study. For non-clinical testing, it would be internal laboratory data generated by Zimmer, Inc.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable as no clinical ground truth was established for this submission.
-
Adjudication Method for the Test Set:
- Not applicable as no clinical ground truth was established for this submission.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical data and conclusions were not needed for this device."
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a physical knee prosthesis component, not an algorithm or AI-driven system.
-
Type of Ground Truth Used:
- Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be established engineering specifications and accepted testing standards for mechanical performance of knee implants.
-
Sample Size for the Training Set:
- Not applicable. This device is a physical knee prosthesis component, not an AI/algorithm-driven system requiring a training set.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable. This device is a physical knee prosthesis component, not an AI/algorithm-driven system requiring a training set.
Conclusion from the Document:
The FDA clearing document (K043101) indicates that the device's safety and effectiveness were demonstrated through non-clinical performance testing and by establishing substantial equivalence to predicate devices. The modifications made to the NexGen MIS Tibial Components were considered "minor" and "do not change the intended use or the fundamental scientific technology." Therefore, detailed clinical studies, specific acceptance criteria in the clinical sense, or sophisticated ground truth establishment methods were not required for this 510(k) clearance.
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MAR 7 - 2005
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Brandon HipsherSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | November 8, 2004 |
| Trade Name: | NexGen ® Complete Knee Solution MIS ™ TibialComponents |
| Common Name: | Total Knee Prosthesis |
| Classification Nameand Reference: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis21 CFR § 888.3560 |
| Predicate Devices: | NexGen Precoat Stemmed Tibial Plates and StemExtensions, manufactured by Zimmer, Inc.,K933785, cleared January 30, 1995.NexGen Locking Screws and Taper Stem Plugs,manufactured by Zimmer, Inc., K991581, clearedJuly 30, 1999.NexGen Porous, Uncemented Femoral and TibialBaseplate Components, manufactured by Zimmer,Inc., K031061, cleared October 3, 2003. |
| Device Description: | The NexGen MIS Tibial Components are part of theNexGen system of semiconstrained, nonlinkedcondylar 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, |
{1}------------------------------------------------
K643101
and the comments of the comments of the comments of the comments of
| particularly when there is patellofemoralerosion, dysfunction or prior patellectomyModerate valgus, varus, or flexiondeformities.- The salvage of previously failed surgicalattempts or for a knee in which satisfactorystability in flexion cannot be obtained at thetime of surgery.This device is intended for cemented use only. | |
|---|---|
| Comparison to Predicate Device: | Except for minor modifications, MIS TibialComponents are identical to the predicate devices.The modifications do not change the intended use othe fundamental scientific technology. The deviceis packaged and sterilized using the same materialsand processes. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Performance testing completed as part of the designassurance process demonstrated that this device issafe and effective and substantially equivalent to thpredicate device. |
| Clinical Performance and Conclusions:Clinical data and conclusions were not needed forthis device. |
and the same of the same of the same of the same
:
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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 stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
MAR 7 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brandon Hipsher Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K043101
KU43101
Trade/Device Name: NexGen® Complete Knee Solution MISTM Tibial Components Regulation Number: 21 CFR 888.3560 Regulation Name: Enee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II
Product Code: JWH Dated: February 4, 2005 Received: February 7, 2005
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the device wE have teviewed your bected. 9 10(2) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1776, the excordance with the provisions of the Federal Food, Drug, de necs mat have been reciasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, morelors, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is elassinod (over as controls. Existing major regulations affecting your device can may oc subject to sach additions, 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 1 that FDA has made a determination that your device complies with other requirements of the Act that I Drivias intatutes and regulations administered by other Federal agencies. You must of any I caefal statuted and regisments, including, but not limited to: registration and listing (21 econfire with an the Not 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of evense (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Brandon Hipsher
This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to begin marketing your article equivalence of your device to a legally premarket notification. The PDA inding of substantial organism to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your active en other and and the regulation entitled, Colliact the Office of Complance at (210) = 16 = 21 807.97). You may obtain Mission of the release to premantonibilities under the Act from the Division of Small be other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octrise http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Melleman
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K043101
Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Complete Knee Solution MIS™ Tibial Components
Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- evice is indicated for patients withis, traumatic arthritis, polyarthritis.
Rheumatoid arthritis, osteoarthritis, traumatic arthritis, । - Rheumatord artifulis, osteourantials, necrosis of the femoral condyle. -
- Collagen disorders and or avascular necrosis of when there is patellofemoral । erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities. l
- Moderate Valgus, Varas of Trekton ugical attempts or for a knee in which ﺖ I he saivage of previously fance surgious atthe fime of surgery.
This device is intended for cemented use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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
710(k) Number
Page 1 of 1
0083
§ 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.