BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

K073567 · Zimmer GmbH · LZO · Mar 13, 2008 · Orthopedic

Device Facts

• Record ID: K073567
• Device Name: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
• Applicant: Zimmer GmbH
• Product Code: LZO · Orthopedic
• Decision Date: Mar 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision 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 ceramic femoral head system; alumina matrix composite head (28, 32, 36, 40 mm diameters) with titanium adapter; designed for primary or revision total hip arthroplasty. Compatible with Zimmer 12/14 femoral stems. Used by orthopedic surgeons in clinical settings. Provides alternative to metal or alumina ceramic heads; accommodates various patient anatomies via range of offsets. Mechanical testing confirms compatibility with femoral stems and ability to withstand in vivo loading.

Clinical Evidence

No clinical data provided; device equivalence established via non-clinical mechanical testing.

Technological Characteristics

Alumina matrix composite ceramic femoral head; titanium adapter. Modular design with 28, 32, 36, and 40 mm diameters. Compatible with Zimmer 12/14 femoral stems. Mechanical testing performed to verify structural integrity under in vivo loading conditions.

Indications for Use

Indicated for patients requiring primary or revision total hip arthroplasty due to severe hip pain/disability from rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, femoral fracture nonunion, 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

• DePuy Delta TS (Taper Sleeve) Ceramic Femoral Head (K071830)

Submission Summary (Full Text)

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K-073567

## Summary of Safety and Effectiveness

MAR 1 3 2008

:

| Submitter: | Zimmer GmbH<br>Sulzer Allee 8<br>Winterthur, Switzerland CH - 8404 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Jenks<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Alternate Contact: | Natalie Heck<br>Sr. Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | March 4, 2008 |
| Trade Name: | BIOLOX® OPTION* Ceramic Femoral Head System |
| 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): | DePuy Delta TS (Taper Sleeve) Ceramic Femoral<br>Head, manufactured by DePuy Orthopaedics, Inc.,<br>K071830, cleared September 28, 2007 |
| Device Description: | The BIOLOX OPTION Ceramic Femoral Head<br>System consist of a ceramic head fabricated from an<br>alumina matrix composite available in diameters of<br>28, 32, 36, and 40 mm and a titanium adapter for<br>the femoral stem cone with a range of offsets to<br>accommodate various patient anatomies. The<br>system serves as an alternative to both metal and<br>alumina ceramic femoral heads and is for use in<br>both primary and revision total hip arthroplasty. |
| Intended Use: | The BIOLOX OPTION Ceramic Femoral Head<br>System is comprised of modular components |

* Trademark of CeramTec AG

:

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| | used in primary or revision 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 OPTION Ceramic Femoral Head<br>System is substantially equivalent to the femoral<br>head system listed above as the predicate device.<br>Both the proposed and predicate designs are<br>intended to function as a modular ceramic femoral<br>head component in total hip arthroplasty and are<br>manufactured by CeramTec AG from the same<br>materials. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | Mechanical testing was performed and results<br>indicate that the BIOLOX OPTION Ceramic<br>Femoral Head System is equivalent to devices<br>currently legally marketed, is compatible with<br>Zimmer 12/14 femoral stems and capable of<br>withstanding <i>in vivo</i> loading. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for<br>this device. |

:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer GmbH c/o Ms. Natalie Heck Senior Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

MAR 1 3 2008

Re: K073567 Trade/Device Name: BIOLOX OPTION Ceramic Femoral Head System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or non porous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: February 19, 2008 Received: February 21, 2008

Dear Ms. Heck:

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. Natalie Heck

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance 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 responsibilities 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 M. Mellersen

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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## K073567

## Indications for Use

510(k) Number (if known):

Device Name:

BIOLOX® OPTION* Ceramic Femoral Head System

## Indications for Use:

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision 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 Ostcourtifies, 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)

Neil RPOgden for mxm

Division of General, Restorative, and Neurological Devices

*Trademark of CeramTec AG

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510(k) Number K073567

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