NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS

K052879 · Zimmer, Inc. · JWH · Nov 22, 2005 · Orthopedic

Device Facts

• Record ID: K052879
• Device Name: NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 22, 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 Modular Tibial Plates and Keels are components of a semiconstrained, nonlinked condylar knee prosthesis system. Designed for cemented implantation in patients requiring total knee arthroplasty due to severe pain or joint disability. The device replaces damaged joint surfaces to restore knee function and stability. Used in clinical surgical settings by orthopedic surgeons. The system is a modification of the predicate NexGen Complete Knee Solution; it maintains the same fundamental scientific technology, materials, and manufacturing processes. The device provides a mechanical solution for joint reconstruction, with clinical outcomes dependent on surgical placement and patient rehabilitation.

Clinical Evidence

No clinical data was required or provided for this device. Substantial equivalence was established through non-clinical performance testing as part of the design assurance process.

Technological Characteristics

Semiconstrained, nonlinked condylar knee prosthesis. Components include modular tibial plates and keels. Intended for cemented use only. Materials and manufacturing processes are identical to the predicate NexGen system. No software or electronic components.

Indications for Use

Indicated for patients with severe knee pain and disability due to rheumatoid, osteoarthritis, traumatic, or polyarthritis; collagen disorders; avascular necrosis of femoral condyle; post-traumatic loss of joint configuration (including patellofemoral erosion/dysfunction or prior patellectomy); or moderate valgus, varus, or flexion deformities. Also indicated for salvage of failed surgical attempts or cases where satisfactory flexion stability is unattainable. 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 Complete Knee Solution (K933785)

Submission Summary (Full Text)

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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>Associate, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | October 11, 2005 |
| Trade Name: | <i>NexGen</i> ® Complete Knee Solution <i>MIS</i> ™ Modular<br>Tibial Plates and Keels |
| 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 Device: | <i>NexGen</i> ® Complete Knee Solution, manufactured<br>by Zimmer, Inc., K933785, cleared January 30,<br>1995 |
| Device Description: | The <i>NexGen MIS</i> Modular Tibial Plates and Keels<br>are part of the <i>NexGen</i> system of semiconstrained,<br>nonlinked condylar knee prostheses. |
| Intended Use: | This device is indicated for patients with severe<br>knee pain and disability due to:<br>- Rheumatoid arthritis, osteoarthritis,<br>traumatic arthritis, polyarthritis.<br>- Collagen disorders, and/or avascular<br>necrosis of the femoral condyle.<br>- Post-traumatic loss of joint configuration,<br>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 |

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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 [phone]. 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 [phone] or [phone] 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