GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM

K070214 · Zimmer, Inc. · MBH · Mar 16, 2007 · Orthopedic

Device Facts

• Record ID: K070214
• Device Name: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Mar 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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. The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Device Story

Semiconstrained, nonlinked condylar knee prosthesis; provides increased flexion capability (up to 155 degrees). System includes GSM (male) and GSF (female) femoral components modified to address specific distal femur anatomical features. Components available with or without CSTi porous coating for cemented or uncemented use. Used by orthopedic surgeons in clinical settings for total knee arthroplasty. Device restores joint function, reduces pain, and corrects deformity in patients with degenerative or inflammatory joint disease. Output is physical restoration of knee joint mechanics; clinical decision-making based on patient anatomy, ligament integrity, and desired range of motion.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and Finite Element Analysis.

Technological Characteristics

Semiconstrained, nonlinked condylar knee prosthesis. Materials include metal and polymer. Features CSTi (Cancellous-Structured Titanium) porous coating for uncemented or cemented fixation. Designed for maximum active flexion of 155 degrees. Mechanical assembly.

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. Designed for patients desiring increased flexion range up to 155 degrees.

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® Complete Knee Solution Knee Gender Solutions Female (GSF) Femoral Components (K060370)
• Natural-Knee II System with Cancellous-Structured Titanium™ (CSTi™) Porous Coating
• Prolong™ Highly Crosslinked Polyethylene Cruciate Retaining Articular Surface Component

Submission Summary (Full Text)

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# MAR 1 6 2007

## Summary of Safety and Effectiveness

....

| 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: | January 22, 2007 |
| Trade Name: | Gender Solutions™ 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><br>Knee joint patellofemorotibial metal/polymer<br>porous-coated uncemented prosthesis<br>21 CFR § 888.3565 |
| Predicate Devices: | NexGen® Complete Knee Solution Knee Gender<br>Solutions Female (GSF) Femoral Components,<br>manufactured by Zimmer, Inc., K060370, cleared<br>April 28, 2006.<br><br>Natural-Knee II System with Cancellous-Structured<br>Titanium™ (CSTi™) Porous Coating, manufactured1997 and reclassified to Class II February 3, 2003.<br><br>Prolong™ Highly Crosslinked Polyethylene<br>Cruciate Retaining Articular Surface Component.December 27, 2001. |

Device Description:

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The Gender Solutions Natural-Knee Flex System is a semiconstrained, nonlinked condylar knee

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prosthesis that is designed to have a maximum active flexion of 155 degrees. The system includes GSM and GSF femoral components; these designations indicate that the design of the femoral components has been modified to address specific anatomical features of the distal femur that can be seen in patients of either gender, but are more typical of male and female patients, respectively.

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.

The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Except for minor geometrical and material modifications, the proposed components are identical to the predicate devices.

Non-Clinical Performance and Conclusions:

Mechanical testing and Finite Element Analysis of the proposed device demonstrates that it is substantially equivalent to the predicate devices.

Clinical Performance and Conclusions:

Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Clinical data and conclusions were not needed for this device.

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100 million and

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2007

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

Re: K070214

> Trade/Device Name: Gender Solutions Natural-Knee Flex System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: March 8, 2007 Received: March 9, 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

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#### Page 2 - Mr. Brandon Hipsher, RAC

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,

Aubrey Muchno

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): K070214

#### Device Name:

## Gender Solutions™ Natural-Knee® Flex System

#### Indications for Use:

- · 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 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.
- · The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use 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 (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)

Daulace Buem

(Division Sign-Oli) Division of General, Restorative, and Neurological Devices

510(k) Number K070214

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