NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS

K050105 · Zimmer, Inc. · JDI · May 17, 2005 · Orthopedic

Device Facts

• Record ID: K050105
• Device Name: NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
• Applicant: Zimmer, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Distal Femoral Spacers are poly(methyl methacrylate) (PMMA) components used in total knee arthroplasty; designed to adjust extension gaps and maintain uniform cement mantle. Used in pairs; each spacer fits over a femoral post of a cemented total knee prosthesis. During surgery, spacers are placed between femoral component and prepared bone; incorporated into cement mantle during polymerization. Available in 2mm and 4mm thicknesses. Operated by orthopedic surgeons in clinical/OR settings. Benefits include improved joint stability and consistent cement distribution.

Clinical Evidence

No clinical data or non-clinical performance testing was required for this device.

Technological Characteristics

Material: poly(methyl methacrylate) (PMMA). Form factor: 2mm and 4mm thickness spacers. Principle: mechanical spacing to maintain cement mantle thickness. Energy source: none (passive). Sterilization: not specified.

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 loss of joint configuration (including patellofemoral erosion/dysfunction/prior patellectomy), or moderate valgus, varus, or flexion deformities. Also indicated for salvage of failed surgical attempts or cases requiring improved flexion stability. Intended for cemented use only.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• ZCA® All-Poly Acetabular Cup, Snap-In (PMMA spacer) (K030153)

Submission Summary (Full Text)

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K050105

## MAY 1 7 2005

### Summary of Safety and Effectiveness

:

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | January 17, 2005 |
| Trade Name: | NexGen® Complete Knee Solution Distal Femoral<br>Spacers |
| Common Name: | Total knee prosthesis |
| Classification Name<br>and Reference: | Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis<br>21 CFR § 888.3560 |
| Predicate Device: | ZCA® All-Poly Acetabular Cup, Snap-In (PMMA<br>spacer) manufactured by Zimmer, Inc., K030153,<br>cleared April 1, 2003. |
| Device Description: | The Distal Femoral Spacer is a poly(methyl<br>methacrylate) [PMMA] cement spacer designed to<br>help adjust extension gaps and maintain a uniform<br>cement mantle when used with the femoral<br>component of a cemented total knee prosthesis. It is<br>used in pairs; each Distal Femoral Spacer fits over<br>one of the femoral posts. This creates a defined<br>space between the femoral component and the<br>prepared bone, helping maintain a uniform cement<br>mantle. The Distal Femoral Spacers themselves are<br>then incorporated into the cement mantle by the<br>polymerizing bone cement. The Distal Femoral<br>Spacer is available in 2mm and 4mm thicknesses. |
| Intended Use: | This device is indicated for patients with severe<br>knee pain and disability due to: |

:

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# 50105

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Rheumatoid arthritis, osteoarthritis, traumatic

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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. The Distal Femoral Spacers are substantially Comparison to Predicate Device: equivalent to the predicate PMMA spacer in that both are manufactured from the same material and are intended to help maintain a uniform cement mantle. Non-Clinical Performance and Conclusions: Performance Data (Nonclinical and/or Clinical): Non-clinical performance testing was not required for this 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.

MAY 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brandon Hipsher Zimmer Incorporated 345 East Main Street Warsaw, Indiana 46580

Re: K050105

Trade/Device Name: Nex Gen® Complete Knee Solution Distal Femoral Spacers Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial metal/ polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI Dated: April 13, 2005 Received: April 14, 2005

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) I mis icher will anow your to organization of substantial equivalence of your device to a legally premarket notification: "The 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 If you desire specific arrivate - J at [phone] . Also, please note the regulation entitled, coniact the Office of Companise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Stypt Rurle

Miriam C. Provost, Ph.D. Acting 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® Complete Knee Solution Distal Femoral Spacers

#### 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. ﺍ
- Conagen disorders and or trussenaration, particularly when there is patellofemoral l 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.

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)

Stupt Purde
(Division Sign-Off)

Division of General, Restorative. and Neurological Devices

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