CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00

K030265 · Zimmer, Inc. · JDI · Mar 4, 2003 · Orthopedic

Device Facts

• Record ID: K030265
• Device Name: CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
• Applicant: Zimmer, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CPT® 12/14 Hip Prostheses are indicated for use with patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis. traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur and in the presence of proximal femoral bone defects; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.

Device Story

CPT 12/14 Hip Prosthesis is a one-piece, straight, collarless, highly polished femoral stem; intended for cemented fixation into intramedullary canal. Used in total hip arthroplasty for patients with degenerative or pathological hip conditions. Device provides structural replacement for femoral head/neck. Implanted by orthopedic surgeons in clinical/OR settings. Benefits include pain relief and restoration of hip function. Device serves as line extension to existing Zimmer femoral stem products.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

One-piece, straight, collarless, highly polished femoral stem. Designed for cemented fixation. Metal/polymer semi-constrained hip prosthesis. Class II device.

Indications for Use

Indicated for patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, femoral nonunion, proximal femoral bone defects, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, previous fusion, failed prior endoprostheses/total hip components, or acute femoral neck fractures.

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

• Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses (K960658)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold "Z" enclosed in a circle on the left, followed by the word "zimmer" in a smaller, lowercase font on the right. The logo is black and white.

030265
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## Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 | MAR 0 4 2003 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Dalene T. Binkley, RAC<br>Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] | |
| Date: | January 21, 2003 | |
| Trade Name: | CPT® 12/14 Hip Prostheses | |
| Common Name: | Total hip prosthesis | |
| Classification Name and Reference: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,<br>Cemented | |
| | 21 CFR § 888.3350 | |
| Predicate Device: | Collarless Polished Taper and Collarless Polished<br>Taper LS Hip Prostheses, manufactured by Zimmer,<br>K960658, cleared July 16, 1996. | |
| Device Description: | The CPT® 12/14, like its predicate, is a one-piece<br>straight, collarless and highly polished femoral stem<br>that is intended to be used for cemented fixation<br>into the intramedullary canal for pathological or<br>degenerative conditions involving the femur and/or<br>acetabulum | |
| Intended Use: | The CPT® 12/14 Hip Prostheses are indicated for<br>use with patients suffering from severe hip pain and<br>disability due to rheumatoid arthritis, osteoarthritis.<br>traumatic arthritis, polyarthritis, collagen disorders,<br>avascular necrosis of the femoral head, and<br>nonunion of previous fractures of the femur and in<br>the presence of proximal femoral bone defects;<br>patients with congenital hip dysplasia, protrusio<br>acetabuli, or slipped capital femoral epiphysis;<br>patients suffering from disability due to previous | |

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fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.

Comparison to Predicate Device: The modifications to the Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses change neither the intended use nor the fundamental scientific technology of the device. It is packaged and sterilized using the same materials and processes. The modified device was created to offer a line extension to provide the surgeon with more options. Performance Data: Non-clinical performance testing demonstrated that the modified devices are equivalent to the predicate.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three horizontal lines above them, possibly representing the concept of health and well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 4 2003

Ms. Dalene T. Binkley Regulatory Affairs Associate Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K030265

Trade/Device Name: CPT 12/14 Hip Prostheses Regulation Numbers: 21 CFR 888.3350 Regulation Names: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: February 18, 2003 Received: February 19, 2003

Dear Ms. Binkley:

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 - Ms. Dalene T. Binkley

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours

Mark N. Milkersen

Celia M. Witten, Ph.D., M.D. 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

K030265

Page 1 of 1

510(k) Number (if known):

Device Name:

CPT® 12/14 Hip Prosthesis

## Indications for Use:

The CPT® 12/14 Hip Prostheses are indicated for use with patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur and in the presence of proximal femoral bone defects; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark H. Millkeun

Division Sign-Off

Division of Cere

and Neurologics

| 510(k) Num | K030265 |
|------------|---------|
|------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
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