ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM

K030724 · Zimmer, Inc. · LZO · Jun 3, 2003 · Orthopedic

Device Facts

• Record ID: K030724
• Device Name: ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
• Applicant: Zimmer, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jun 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alumina Ceramic Femoral Heads are modular components designed for use in total hip arthroplasty and indicated for the following: 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; 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 operative extremity; and patients with acute neck fractures.

Device Story

Alumina ceramic femoral heads (28mm and 32mm) serve as modular components in total hip arthroplasty. Devices feature 12/14 bore designed to mate with titanium or cobalt-chromium alloy femoral stems via 12/14 neck taper. Intended for single-use; implanted by surgeons during hip replacement procedures. Ceramic material provides articulation surface for hip joint. Benefit includes restoration of hip function and pain relief for patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Mechanical testing performed per FDA Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems. Results demonstrate equivalence to currently marketed devices and capacity to withstand in vivo loading.

Technological Characteristics

Material: Alumina (Al2O3) ceramic. Form factor: 28 mm and 32 mm diameter femoral heads with 12/14 bore. Connectivity: None (mechanical interface). Sterilization: Not specified. Software: None.

Indications for Use

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

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Zimmer Ceramic Femoral Heads (K905739)
• Zimmer Ceramic Femoral Heads (K914676)

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, stylized "Z" inside of a circle on the left, and the word "zimmer" in bold, sans-serif font on the right. The logo is black and white.

## JUN - 3 2003

## Summary of Safety and Effectiveness

030724
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| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Cain<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | March 3, 2003 |
| Trade Name: | Alumina Ceramic Femoral Heads, 28 and 32 mm |
| Common Name: | Ceramic Femoral Head Prosthesis |
| Classification Name<br>and Reference: | Hip joint metal/ceramic/polymer semiconstrained<br>cemented or nonporous uncemented prosthesis<br>21 CFR § 888.3353 |
| Predicate Devices: | Zimmer Ceramic Femoral Heads, K905739 and<br>K914676, cleared March 7, 1991, and January 13,<br>1992, respectively. |
| Device Description: | The Alumina Ceramic Femoral Heads are single-<br>use devices manufactured from Al ₂ O ₃ . Both 28 and<br>32 mm diameter heads are available in three neck<br>lengths each. The 12/14 bore of the ceramic ball<br>mates with Zimmer titanium and cobalt-chromium<br>alloy femoral stems having a corresponding 12/14<br>neck taper. |
| Indications for Use: | The Alumina Ceramic Femoral Heads are modular<br>components designed for use in total hip<br>arthroplasty and indicated for the following:<br>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;<br>patients with congenital hip dysplasia, protrusio |

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Image /page/1/Picture/2 description: The image shows handwritten text that appears to be a combination of an identifier and page information. The text "KO 30724" is written on the top line, likely serving as a document or project identifier. Below this, the text "page 2 of 2" indicates that this is the second page of a two-page document.

Comparison to Predicate Device:

Performance Data:

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 operative extremity; and patients with acute neck fractures.

The Alumina Ceramic Femoral Heads are substantially equivalent to the femoral heads listed above as predicate devices. Both designs are intended to function as a modular femoral head component in hip arthroplasty and are manufactured from AbO3 ceramic.

Mechanical testing was performed per the FDA Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems. Test results indicate that the Alumina Ceramic Femoral Heads are equivalent to devices currently on the market and capable of withstanding in vivo loading.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2003

Ms. Karen Cain Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K030724

Trade/Device Name: Alumina Ceramic Femoral Heads, 28 and 32 mm Regulation Numbers: 21 CFR 888.3353 Regulation Names: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Codes: LZO Dated: March 3, 2003 Received: March 7, 2003

Dear Ms. Cain:

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. Iisting 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

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Page 2- Ms. Karen Cain

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/dsma/dsmamain.html

Sincerely vours.

R. Mark N. Wilkerson

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

KO30724

510(k) Number (if known):

Device Name:

Alumina Ceramic Femoral Heads, 28 and 32 mm

Indications for Use:

The Alumina Ceramic Femoral Heads are modular components designed for use in total hip arthroplasty and indicated for the following:

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; 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 operative extremity; and patients with acute neck fractures.

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

Concurrence of CDRH, Office of Device Evaluation


(Division Sign-Off)
Division of General. Restorative
and Neurological Devices

| 510(k) Number | K030724 |
|---------------|---------|
|---------------|---------|

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

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