NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS

K060370 · Zimmer, Inc. · JWH · Apr 28, 2006 · Orthopedic

Device Facts

• Record ID: K060370
• Device Name: NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Apr 28, 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 intended for cemented use only. Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90prefix 17 or 20mm Prolong™ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

Device Story

NexGen Knee Gender Solutions Female (GSF) Femoral Components are semiconstrained, nonlinked, condylar knee prostheses; designed for maximum active flexion of 155 degrees. Device features slight modifications to address specific distal femur anatomic features more typical of female patients. Components include LPS-Flex GSF and CR-Flex GSF versions. Used in total knee arthroplasty; implanted by orthopedic surgeons in clinical settings. Device provides increased flexion capability for patients desiring greater range of motion. CR-Flex GSF requires functional posterior cruciate ligament; LPS-Flex GSF used when both cruciate ligaments are excised. Output is a restored joint surface; improves patient mobility and reduces pain.

Clinical Evidence

No clinical data.

Technological Characteristics

Semiconstrained, nonlinked, condylar knee prosthesis; metal/polymer construction. Designed for cemented use only. Maximum active flexion of 155 degrees. Includes LPS-Flex GSF and CR-Flex GSF versions. Materials and sterilization processes are identical to predicate devices.

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, patellofemoral erosion/dysfunction, prior patellectomy, or moderate valgus/varus/flexion deformities. Also indicated for salvage of failed surgical attempts or knee instability. 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 LPS-Flex knee (K991581)
• NexGen CR-Flex femoral component (K023211)

Submission Summary (Full Text)

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K160370 page 174

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# Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen McKelvey, MA, RAC Manager, Corporate Regulatory Affairs Telephone: [phone] Fax: [phone] |
| Date: | February 10, 2006 |
| Trade Name: | <i>NexGen</i> ^® Knee Gender Solutions Female (GSF) Femoral Components |
| Common Name: | Total Knee Prosthesis |
| Classification Name and Reference: | Knee joint, patellofemorotibial, metal/polymer, semi-constrained, cemented prosthesis 21 CFR § 888.3560 |
| Predicate Devices: | <i>NexGen</i> LPS-Flex knee, manufactured by Zimmer, K991581, cleared July 30, 1999 and the <i>NexGen</i> CR-Flex femoral component, manufactured by Zimmer, K023211, cleared October 17, 2002 |
| Device Description: | The <i>NexGen</i> Knee GSF Femoral Components include both LPS-Flex GSF and CR-Flex GSF versions and are part of the Zimmer Flex-series of semiconstrained, nonlinked, condylar knee prostheses that are designed to have a maximum active flexion of 155 degrees. The GSF designation indicates that the design of the femoral component has been modified slightly to address specific anatomic features of the distal femur that can be seen in both male and female patients, but are more typical of a female patient. |
| 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 |

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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.

Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90prefix 17 or 20mm Prolong™ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

Except for modifications to address specific anatomic features typical of a female patient, these components are identical to their respective predicate device. The device is packaged and

Performance Data (Nonclinical and/or Clinical):

Comparison to Predicate Device:

Non-Clinical Performance and Conclusions:

sterilized using the same materials and processes.

Mechanical testing and Finite Element Analysis of the NexGen Knee GSF Femoral Components indicate that they are substantially equivalent to the predicate devices.

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 and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

a Julia

Zimmer, Inc. c/o Mr. Stephen McKelvey, MA, RAC Manager, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K060370 Trade/Device Name: NexGen® Knee Gender Solutions Female (GSF) Femoral Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, patellofemorotibial, polymer/metal/polymer, semiconstrained, cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 10, 2006 Received: February 13, 2006

Dear Mr. McKelvey:

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

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Page 2 - Mr. Stephen McKelvey, MA, RAC

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 McMillan

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® Knee Gender Solutions Female (GSF) Femoral Components

#### 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.

This device is intended for cemented use only.

Specific uses with CR-Flex GSF or LPS-Flex GSF femorals:

- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong™ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
- The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use
No
(21 CFR 807 Subpart C) /アビ

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulm Lemuta

Division of General, Restorati and Neurological Devic

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**510(k) Number** Koio'370