MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS

K050723 · Zimmer, Inc. · JWH · Apr 20, 2005 · Orthopedic

Device Facts

• Record ID: K050723
• Device Name: MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Apr 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total knee replacement is indicated for patients suffering from severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, or pseudogout. These devices are intended for cemented use only.

Device Story

MG II Total Knee System Stemmed Tibial Baseplate Components are orthopedic implants used in total knee replacement surgery. The system features a central stem with modular stem extensions; available in Porous, PMMA Precoat, and Option (non-coated) versions. Used by orthopedic surgeons in clinical settings to replace damaged knee joints. The device is implanted to alleviate pain and restore function in patients with severe arthritis or related joint disorders. It is compatible with existing MG II articular surface components. The device is intended for cemented fixation only.

Clinical Evidence

No clinical data.

Technological Characteristics

Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis. Components include central stem with modular extensions. Available in Porous, PMMA Precoat, and non-coated versions. Sterilized using established processes.

Indications for Use

Indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary/secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, or pseudogout. 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

• MG II Porous Total Knee System (K892800)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a large, stylized "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The font is bold and sans-serif. The logo is black and white.

Special 510(k): Device Modification

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| APR | 20 | 2005 |
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Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
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| Contact Person: | Brandon Hipsher<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | March 18, 2005 |
| Trade Name: | MG II™ Total Knee System Stemmed Tibial<br>Baseplate Components |
| Common Name: | Total Knee Prosthesis |
| Classification Name<br>and Reference: | Knee joint patellofemorotibial polymer/metal/polymer<br>semi-constrained cemented prosthesis<br>21 CFR § 888.3560 |
| Predicate Device: | MG II Porous Total Knee System, manufactured by<br>Zimmer, Inc., K892800, cleared August 3, 1989 |
| Device Description: | Stemmed tibial baseplate components are part of the<br>MG II Total Knee System. They incorporate a<br>central stem with available modular stem<br>extensions. There are three versions of stemmed<br>tibial baseplate components: Porous, PMMA<br>Precoat, and Option (non-coated). They are<br>available in the same size range, and are compatible<br>with the same articular surface components, as the<br>predicate device. |
| Intended Use: | Total knee replacement is indicated for patients<br>suffering from severe knee pain and disability due<br>to rheumatoid arthritis, osteoarthritis, primary and<br>secondary traumatic arthritis, polyarthritis, collagen<br>disorders, avascular necrosis of the femoral<br>condyle, or pseudogout. |
| | These devices are intended for cemented use only. |

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## Comparison to Predicate Device:

Except for minor modifications, MG II Stemmed Tibial Baseplate Components are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged and sterilized using the same materials and processes.

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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APR 2 0 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: K050723

K050723
Trade/Device Name: MG IJ™ Total Knee System Stemmed Tibial Baseplate Components Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II

Product Codes: JWH Dated: March 18, 2005 Received: March 21, 2005

Dear Mr. Hipsher:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosed. 976, the enactment date of the Medical Device Amendments, or to conninered province that have been reclance with the provisions of the Federal Food, Drug, devices mat have been recuire a require approval of a premarket approval application (PMA). allu Cosmetic Ac, (110) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mainer of the Act include requirements for annual registration, listing of general condois provisions 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 IT your device is classified (600 as 310) of on the major regulations affecting your device can may be subject to subli duditions, 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 I least of advised that I Drivisounces at your device complies with other requirements of the Act that I DA has made a availations administered by other Federal agencies. You must of any I cacal statutes and regalabents and limited to: registration and listing (21 Comply with an the Her STequirements)01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bycrents (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 510(k) This letter will anow you to begin manceling your and equivalence of your device to a legally premaired notincation: The PPA intelligence 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 If you desire specific advice for your access in the regulation of the regulation entitled, contact the Office of Compilance an (21 ) = (21CFR Part 807.97). You may obtain Misolanding by reference to promanteensbilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, international and Octass http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stepto Rhodes

Miriam Provost, Ph.D.

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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## Indications for Use

510(k) Number (if known):

K050723

Device Name:

MG II" Total Knee System Stemmed Tibial Baseplate Components

## Indications for Use:

Total knee replacement is indicated for patients suffering from severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, or pseudogout.

These devices are intended for cemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

.

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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)

Stypt Rurds
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number_________________________________________________________________________________________________________________________________________________________________