BIOLOX DELTA CERAMIC FEMORAL HEAD

K071535 · Zimmer, Inc. · LZO · Nov 19, 2007 · Orthopedic

Device Facts

• Record ID: K071535
• Device Name: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Applicant: Zimmer, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIOLOX delta Ceramic Femoral Heads are modular components used 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

Modular femoral head component for total hip arthroplasty; fabricated from alumina matrix composite ceramic; available in 28, 32, 36, and 40 mm diameters with various offsets; used by orthopedic surgeons in clinical settings; serves as alternative to metal or alumina ceramic heads; provides structural interface between femoral stem and acetabular component; mechanical design allows for modular assembly; benefits patient by restoring hip function and reducing pain associated with degenerative or traumatic joint conditions.

Clinical Evidence

No clinical data; bench testing only. Mechanical testing results indicate the device is equivalent to currently marketed devices and capable of withstanding in vivo loading.

Technological Characteristics

Alumina matrix composite ceramic; modular femoral head design; available in 28, 32, 36, and 40 mm diameters; intended for use in total hip arthroplasty; non-porous surface.

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, nonunion of femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, previous fusion, failed endoprostheses, 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

• 36mm Biolox delta Ceramic Heads (K061312)
• DePuy Delta Ceramic Femoral Head (K062748)
• V40 Biolox delta Ceramic Femoral Heads (K052718)

Submission Summary (Full Text)

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# Қ071535

## Summary of Safety and Effectiveness

NOV 1 9 2007

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Jenks<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | June 4, 2007 |
| Trade Name: | BIOLOX ^® delta* Ceramic Femoral Head |
| Common Name: | Ceramic Femoral Head Prosthesis |
| Classification Name and<br>Reference: | Hip joint metal/ceramic/polymer semiconstrained<br>cemented or nonporous uncemented prosthesis<br>21 CFR § 888.3353 |
| Predicate Device(s): | 36mm Biolox delta Ceramic Heads, manufactured<br>by Biomet, K061312, cleared June 6, 2006<br>DePuy Delta Ceramic Femoral Head, manufactured<br>by DePuy, K062748, cleared November 30, 2006<br>V40 ^TM Biolox delta Ceramic Femoral Heads,<br>manufactured by Howmedica Osteonics, K052718,<br>cleared October 27, 2005 |
| Device Description: | The BIOLOX delta Ceramic Femoral Heads are<br>fabricated from an alumina matrix composite and<br>are available in diameters of 28, 32, 36, and 40 mm<br>with a range of offsets to accommodate various<br>patient anatomies. They serve as an alternative to<br>both metal and alumina ceramic femoral heads for<br>use in total hip arthroplasty. |

* Trademark of CeramTec: AG

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| Intended Use: | The BIOLOX delta Ceramic Femoral Heads are<br>modular components used in total hip arthroplasty<br>and indicated for the following: |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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<br>acetabuli, or slipped capital femoral epiphysis;<br>patients suffering from disability due to previous<br>fusion; patients with previously failed<br>endoprostheses and/or total hip components in the<br>operative extremity; and patients with acute neck<br>fractures. |
| Comparison to Predicate Device(s): | The BIOLOX delta Ceramic Femoral Heads are<br>substantially equivalent to the femoral heads listed<br>above as predicate devices. Both the proposed and<br>predicate designs are intended to function as a<br>modular femoral head component in total hip<br>arthroplasty and are manufactured from the same<br>materials. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Mechanical testing was performed and results<br>indicate that the BIOLOX delta Ceramic Femoral<br>Heads are equivalent to devices currently on the<br>market and capable of withstanding in vivo loading. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for<br>this device. |

and the comments of the comments of

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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 features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

NOV 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. c/o Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

> K071535 Trade/Device Name: Biolox® delta Ceramic Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: October 25, 2007 Received: October 26, 2007

Dear Ms. Jenks:

Re:

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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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 logally 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 Compliario 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 the reporting 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 responsiblities 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 Wilkerson

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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# K071535

## Indications for Use

510(k) Number (if known):

Device Name:

BIOLOX® delta* Ceramic Femoral Head

#### Indications for Use:

The BIOLOX delta Ceramic Femoral Heads are modular components used 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.

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)

Sabara Cuchup

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K071535

*Trademark of CentuaTes AG