GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM

K073286 · Zimmer, Inc. · JWH · Mar 7, 2008 · Orthopedic

Device Facts

• Record ID: K073286
• Device Name: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Mar 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

N-K Flex System: Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

Device Story

Gender Solutions Natural-Knee Flex System is a semiconstrained, nonlinked condylar knee prosthesis; designed for maximum active flexion of 155 degrees. Device components replace damaged knee joint surfaces to rehabilitate function in patients with degenerative or inflammatory joint disease. Used in surgical settings by orthopedic surgeons. Provides increased flexion capability for patients desiring greater range of motion. Substantial equivalence established via mechanical testing comparing subject device to predicate systems.

Clinical Evidence

No clinical data provided; substantial equivalence supported by non-clinical mechanical testing.

Technological Characteristics

Semiconstrained, nonlinked condylar knee prosthesis; includes options with and without CSTi porous coating. Materials include metal and polymer. Designed for maximum active flexion of 155 degrees.

Indications for Use

Indicated for skeletally mature patients with intact medial and lateral collateral ligaments requiring primary knee surgery for NIDJD or IJD; also indicated for patients with correctable varus-valgus deformity, moderate flexion contracture, or failed previous surgery.

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

• Gender Solutions Natural-Knee Flex System (K070214)
• Zimmer Patellofemoral Joint Prosthesis (K070695)

Submission Summary (Full Text)

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K073286 i/a

## Summary of Safety and Effectiveness

# MAR - 7 2008

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher, RAC<br>Associate Manager, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | March 3, 2008 |
| Trade Name: | Gender Solutions ^TM Natural-Knee ^® Flex System |
| 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<br>Knee joint patellofemorotibial metal/polymer<br>porous-coated uncemented prosthesis<br>21 CFR § 888.3565<br>Knee joint patellofemoral polymer/metal<br>semiconstrained cemented prosthesis<br>21 CFR § 888.3540 |
| Predicate Devices: | Gender Solutions Natural-Knee Flex System,<br>manufactured by Zimmer, Inc., K070214, cleared<br>March 16, 2007.<br>Zimmer Patellofemoral Joint Prosthesis,<br>manufactured by Zimmer, Inc., K070695, cleared<br>June 7, 2007. |
| Device Description: | The Gender Solutions Natural-Knee Flex (N-K<br>Flex) components are semiconstrained, nonlinked<br>condylar knee prosthesis that are designed to have a<br>maximum active flexion of 155 degrees. The N-K<br>Flex femoral provides increased flexion capability |

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for patients who have both the flexibility and desire to increase their flexion range.

:

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| Intended Use: | N-K Flex System:<br>Components with <i>CSTi</i> porous coating are<br>indicated for uncemented or cemented use in<br>skeletally mature individuals with intact medial<br>and lateral collateral ligaments undergoing<br>primary surgery for rehabilitating knees<br>damaged as a result of Noninflammatory<br>Degenerative Joint Disease (NIDJD) or<br>Inflammatory Joint Disease (IJD). Components without <i>CSTi</i> porous coating are<br>indicated for cemented use in skeletally mature<br>individuals with intact medial and lateral<br>collateral ligaments with conditions of<br>Noninflammatory Degenerative Joint Disease<br>(NIDJD) or Inflammatory Joint Disease (IJD),<br>correctable varus-valgus deformity and<br>moderate flexion contracture, or failed previous<br>surgery where pain, deformity or dysfunction<br>persists. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | Except for dimensional and material modifications,<br>the subject components are identical to the predicate<br>device. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Mechanical testing of the subject devices<br>demonstrates that they are substantially equivalent<br>to the predicate devices.<br>Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for<br>these devices. |

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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 consists of a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. % Mr. Brandon Hipsher P.O. Box 708 Warsaw, Indiana 46581-0708

MAR - 7 2008

Re: K073286 Trade/Device Name: Gender Solutions " Natural-Knee" Flex System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prothesis Regulatory Class: II Product Code: JWH, MBH, KRR Dated: March 3, 2008 Received: March 5, 2008

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

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours.

Mark N Millman

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): K073286

Device Name:

Gender Solutions™ Natural-Knee® Flex System

#### Indications for Use:

Gender Solutions" Natural-Knee® Flex System:

- Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
- · Components without CST are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

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)

NishAr Ogl Ev mxn

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Division of General, Restorative, and Neurological Devices

510(k) Number K073286