NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS

K043101 · Zimmer, Inc. · JWH · Mar 7, 2005 · Orthopedic

Device Facts

• Record ID: K043101
• Device Name: NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

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 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.

Device Story

NexGen MIS Tibial Components are semiconstrained, nonlinked condylar knee prostheses; part of the NexGen system. Used in total knee arthroplasty to replace damaged joint surfaces; intended for cemented fixation. Operated by orthopedic surgeons in clinical/hospital settings. Device provides mechanical stability and joint articulation for patients with severe knee pain/disability. Output is a restored joint configuration; aids clinical decision-making by addressing structural joint failure and pain. Benefits include improved mobility and pain relief.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semiconstrained, nonlinked condylar knee prosthesis. Metal/polymer construction. Designed for cemented use. Part of the NexGen system. No software or electronic components.

Indications for Use

Indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, post-traumatic joint loss, or moderate valgus/varus/flexion deformities. Also indicated for salvage of failed surgical attempts or knees lacking stability in flexion. Intended for cemented use only.

Regulatory Classification

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).

Predicate Devices

• NexGen Precoat Stemmed Tibial Plates and Stem Extensions (K933785)
• NexGen Locking Screws and Taper Stem Plugs (K991581)
• NexGen Porous, Uncemented Femoral and Tibial Baseplate Components (K031061)

Submission Summary (Full Text)

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K043101

## MAR 7 - 2005

### Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | November 8, 2004 |
| Trade Name: | <i>NexGen</i> ^® Complete Knee Solution <i>MIS</i> ™ Tibial<br>Components |
| Common Name: | Total Knee Prosthesis |
| Classification Name<br>and Reference: | Knee joint patellofemorotibial polymer/metal/<br>polymer semi-constrained cemented prosthesis<br>21 CFR § 888.3560 |
| Predicate Devices: | <i>NexGen</i> Precoat Stemmed Tibial Plates and Stem<br>Extensions, manufactured by Zimmer, Inc.,<br>K933785, cleared January 30, 1995.<br><i>NexGen</i> Locking Screws and Taper Stem Plugs,<br>manufactured by Zimmer, Inc., K991581, cleared<br>July 30, 1999.<br><i>NexGen</i> Porous, Uncemented Femoral and Tibial<br>Baseplate Components, manufactured by Zimmer,<br>Inc., K031061, cleared October 3, 2003. |
| Device Description: | The <i>NexGen MIS</i> Tibial Components are part of the<br><i>NexGen</i> system of semiconstrained, nonlinked<br>condylar knee prostheses. |
| Intended Use: | This device is indicated for patients with severe<br>knee pain and disability due to:<br><ul><li>Rheumatoid arthritis, osteoarthritis,<br/>traumatic arthritis, polyarthritis.</li><li>Collagen disorders, and/or avascular<br/>necrosis of the femoral condyle.</li><li>Post-traumatic loss of joint configuration,</li></ul> |

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# K643101

and the comments of the comments of the comments of the comments of

| | particularly when there is patellofemoral<br>erosion, dysfunction or prior patellectomy<br>Moderate valgus, varus, or flexion<br>deformities.<br>- The salvage of previously failed surgical<br>attempts or for a knee in which satisfactory<br>stability in flexion cannot be obtained at the<br>time of surgery.<br>This device is intended for cemented use only. |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | Except for minor modifications, MIS Tibial<br>Components are identical to the predicate devices.<br>The modifications do not change the intended use o<br>the fundamental scientific technology. The device<br>is packaged and sterilized using the same materials<br>and processes. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br><br>Performance testing completed as part of the design<br>assurance process demonstrated that this device is<br>safe and effective and substantially equivalent to th<br>predicate device. |
| | Clinical Performance and Conclusions:<br><br>Clinical data and conclusions were not needed for<br>this 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 [phone] 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

K043101

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