NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT

K060722 · Zimmer, Inc. · JWH · May 26, 2006 · Orthopedic

Device Facts

• Record ID: K060722
• Device Name: NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: May 26, 2006
• Decision: SESE
• Submission Type: Traditional
• 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 indicated for use when the posterior cruciate ligament is absent or deficient. This device is intended for use as part of a cemented or uncemented knee prosthesis.

Device Story

NexGen Complete Knee Solution UC-Flex is a fixed-bearing articular surface component for total knee arthroplasty; part of a semiconstrained, nonlinked condylar knee system. Used in clinical settings by orthopedic surgeons; implanted as part of a cemented or uncemented knee prosthesis. Designed for patients with severe knee pain, disability, or ligamentous deficiency (posterior cruciate ligament absent/deficient). Device provides structural support and joint articulation to restore knee function and stability. Substantial equivalence established via comparison to predicate; no clinical data required.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fixed-bearing articular surface component for total knee prosthesis. Semiconstrained, nonlinked design. Manufactured using same materials and processes as predicate device. Intended for cemented or uncemented use.

Indications for Use

Indicated for patients with severe knee pain/disability due to RA, OA, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of femoral condyle, or post-traumatic joint loss (with patellofemoral erosion/dysfunction/prior patellectomy). Also for moderate valgus, varus, or flexion deformities, salvage of failed surgeries, or knees with unstable flexion. Indicated when posterior cruciate ligament is absent/deficient.

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

• Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component (K013991)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

| Submitter: | MAY 26 2006<br>Zimmer, Inc.<br>P.O. Box 708 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Warsaw, IN 46581-0708 |
| Contact Person: | Brandon Hipsher<br>Associate, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | March 16, 2006 |
| Trade Name: | <i>NexGen</i> ® Complete Knee Solution Ultracongruent<br>(UC-Flex) Fixed Bearing Articular Surface<br>Component |
| 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 |
| | Knee joint patellofemorotibial metal/polymer<br>porous-coated uncemented prosthesis<br>21 CFR § 888.3565 |
| Predicate Device: | <i>Prolong</i> ™ Highly Crosslinked Polyethylene<br>Cruciate Retaining (CR) Articular Surface<br>Component, manufactured by Zimmer, Inc.,<br>K013991, cleared December 27, 2001 |
| Device Description: | This device is part of the <i>NexGen</i> system 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, traumatic<br>arthritis, polyarthritis.<br>- Collagen disorders and/or avascular necrosis of<br>the femoral condyle.<br>- Post-traumatic loss of joint configuration |

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particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

- Moderate valgus, varus or flexion deformities. ﮯ
- 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 indicated for use when the posterior cruciate ligament is absent or deficient. This device is intended for use as part of a cemented or uncemented knee prosthesis.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

The proposed device is manufactured, packaged and sterilized using the same materials and processes as the predicate device.

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 6 2006

Zimmer, Inc. % Mr. Brandon Hipsher, RAC Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K060722

Trade/Device Name: NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH, MBH

Dated: March 16, 2006 Received: March 17, 2006

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

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Page 2 - Mr. Brandon Hipsher

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,

Herbert Lerner us

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): KO607222

### Device Name:

NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component

### Indications for Use:

This device is indicated for patients with severe knee pain and disability due to:

- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. l
- 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 indicated for use when the posterior cruciate ligament is absent or deficient.

This device is intended for use as part of a cemented or uncemented knee prosthesis.

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)

Helene Lehner

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K060722

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