NEXGEN TRABECULAR METAL TIBIAL TRAY

K072160 · Zimmer, Inc. · MBH · Sep 5, 2007 · Orthopedic

Device Facts

• Record ID: K072160
• Device Name: NEXGEN TRABECULAR METAL TIBIAL TRAY
• Applicant: Zimmer, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Sep 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3565
• 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. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation).

Device Story

NexGen Trabecular Metal (TM) Tibial Tray is a component of the NexGen semiconstrained, nonlinked condylar knee prosthesis family. Device serves as a tibial baseplate for total knee arthroplasty. Implanted by orthopedic surgeons in a clinical/OR setting to replace damaged joint surfaces. Provides structural support for the knee joint; facilitates biological fixation or use with bone cement. Benefits patients by restoring joint function and reducing pain associated with severe arthritis, deformities, or failed previous surgeries.

Clinical Evidence

No clinical data provided; device determined substantially equivalent based on non-clinical mechanical testing.

Technological Characteristics

Semiconstrained, nonlinked condylar knee prosthesis component. Features Trabecular Metal (TM) porous coating for biological fixation. Compatible with bone cement. Metallic construction. Designed for use within the NexGen knee system.

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 femoral condyle, post-traumatic joint loss, patellofemoral erosion/dysfunction, prior patellectomy, moderate valgus/varus/flexion deformities, or failed prior surgical attempts requiring salvage.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• NexGen Porous, Uncemented Tibial Baseplates (K031061)

Submission Summary (Full Text)

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# K072160

## Summary of Safety and Effectiveness

# SEP - 5 2007

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher, RAC<br>Senior Associate, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | August 3, 2007 |
| Trade Name: | <i>NexGen</i> ® Trabecular Metal™ Tibial Tray |
| Common Name: | Total Knee Prosthesis |
| Classification Name<br>and Reference: | Knee joint patellofemorotibial<br>polymer/metal/polymer semiconstrained cemented<br>prosthesis<br>21 CFR § 888.3560 |
| | Knee joint patellofemorotibial metal/polymer<br>porous-coated uncemented prosthesis<br>21 CFR § 888.3565 |
| Predicate Device: | <i>NexGen</i> Porous, Uncemented Tibial Baseplates,<br>manufactured by Zimmer, Inc., K031061, cleared<br>October 9, 2003. |
| Device Description: | The <i>NexGen</i> Trabecular Metal (TM) Tibial Tray is<br>part of the Zimmer <i>NexGen</i> family of<br>semiconstrained, nonlinked condylar knee<br>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 |

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| | - 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. |
| | <i>NexGen TM Tibial Trays</i> may be used with or without bone cement (biological fixation). |
| Comparison to Predicate Device: | Except for minor modifications, the <i>NexGen TM Tibial Tray</i> is identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. |
| Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | Mechanical testing of the subject device demonstrated that it is substantially equivalent to the predicate device. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for this device. |

. . . . .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2007

Zimmer, Inc. % Mr. Brandon Hipsher, RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, IN 46581

Re: K072160 Trade/Device Name: NexGen® Trabecular Metal™ Tibial Tray Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial/metal/metal constrained cemented prothesis Regulatory Class: II Product Code: MBH, JWH Dated: August 31, 2007 Received: September 5, 2007

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 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.

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Page 2 - Mr. Brandon Hipsher, RAC

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Harbara Buenn

Mark N. Melkerson 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® Trabecular Metal™ Tibial Tray

#### 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 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.

NexGen TM Tibial Trays may be used with or without bone cement (biological fixation).

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)

Barbara Bourin

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K072160