DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

K053536 · Zimmer GmbH · KWA · Mar 16, 2006 · Orthopedic

Device Facts

• Record ID: K053536
• Device Name: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
• Applicant: Zimmer GmbH
• Product Code: KWA · Orthopedic
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. Those patients with failed previous surgery where pain deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

Device Story

Total hip prosthesis system comprising modular CoCrMo alloy femoral heads (38-60mm), CoCrMo neck adapters, and metal monoblock Durom acetabular cup with titanium plasma spray coating. Designed for press-fit fixation in acetabulum; compatible with 12/14 taper femoral stems. Used by orthopedic surgeons in clinical/surgical settings for hip arthroplasty. Provides structural replacement of hip joint to restore mobility and reduce pain in patients with degenerative or inflammatory joint disease. System allows for variation in neck length via modular adapters.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical analysis.

Technological Characteristics

Materials: CoCrMo alloy (femoral heads, neck adapters), titanium plasma spray coating (acetabular cup). Design: Modular femoral heads (38-60mm), monoblock acetabular cup (44-66mm), 12/14 taper compatibility. Fixation: Press-fit. Energy source: None (mechanical).

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (avascular necrosis, osteoarthritis), inflammatory joint disease (rheumatoid arthritis), failed previous surgery with persistent pain/deformity/dysfunction, or revision of failed hip arthroplasty. Applicable to younger patients if clinical indications outweigh age-related risks and activity/loading demands are managed.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• Biomet M²A Magnum System (K042037)
• Wright Metal Transcend Articular System (K021349)
• Centerpulse/Zimmer Epsilon™ Metasul® Acetabular Insert and Metasul Modular Femoral Head (K033634)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

| Submitter | Zimmer GmbH<br>Sulzer Allee 8<br>Winterthur, Switzerland CH-8404 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Laura D. Williams, RAC<br>Manager, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date | December 16, 2005 |
| Trade Name | Durom® Acetabular Component<br>Metasul® LDH™ Large Diameter Heads |
| Common Name | Total hip prosthesis |
| Classification Name | Hip joint metal/metal semi-constrained, with an uncemented<br>acetabular component, prosthesis |
| Classification Reference | 21 CFR § 888.3330 |
| Predicate Devices | • Biomet M²A Magnum System (K042037)<br>• Wright Metal Transcend Articular System (K021349)<br>• Centerpulse/Zimmer Epsilon™ Metasul® Acetabular Insert<br>and Metasul Modular Femoral Head (K033634) |
| Device Description | The Metasul LDH large diameter head system consists of large<br>diameter femoral heads, Durom acetabular components and neck<br>adapters for neck length variation.<br><br>The Metasul LDH femoral heads are made of CoCrMo alloy, and<br>are available in diameters ranging from 38 to 60mm. They are<br>modular in design, and are for use with four head/neck length<br>adaptors (-4 to +8mm), also manufactured from CoCrMo alloy.<br>The femoral heads and neck adapters are compatible with 12/14<br>taper femoral stems.<br><br>The Durom Acetabular component is a metal monoblock<br>CoCrMo alloy cup with a coating of titanium plasma spray. It is<br>available is sizes from 44 to 66mm, and is intended for press-fit<br>fixation in the acetabulum. |
| Intended Use | Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. Those patients with failed previous surgery where pain deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. |
| Comparison to Predicate Device | The proposed device has the same intended use, has similar performance characteristics, is manufactured from similar materials using similar processes, and is similar in design to the predicate devices. |
| Performance Data (Nonclinical and/or Clinical) | The results of non-clinical analysis demonstrate that the device is safe and effective and substantially equivalent to the predicate device(s). |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2006

Zimmer GmbH c/o Ms. Laura D. Williams, RAC Manager, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K053536

K03330
Trade/Device Name: Durom® Acetabular Component and Metasul® LDH® Large Drameter Heads Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA Dated: December 16, 2005 Received: December 19, 2005

Dear Ms. Williams:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energy, 1976, the enactment date of the Medical Device Amendments, or to conimer of the 1125 2011-12-2011 accordance with the provisions of the Federal Food, Drug, de vices mat na v been require approval of a premarket approval application (PMA). and Cosmetic Act (11ct) market the device, subject to the general controls provisions of the Act. The r ou may, aterely mains of the Act include requirements for annual registration, listing of general controls provision 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 n your de rio is exactives (tional controls. Existing major regulations affecting your device can may or bay to to 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 ^ { 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

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Page 2 - Ms. Laura D. Williams

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) I his letter will anow you to oegin maneting of substantial equivalence of your device to a legally prematication. The PDA muding of backand of 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 il you desire specific advice for your aconce en 0.20. Also, please note the regulation entitled, Contact the Office of Comphanes at (210) = 16 = 21 807.97). You may obtain Missianding by relevelee to premailso nibilities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Semper

Mark N. Melkerson Acting Director Division of General, Restorative and and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K053536

510(k) Number (if known):

Device Name:

Durom® Acetabular Component Metasul® LDH® Large Diameter Heads

Indications for Use:

- · Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- · Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of previously failed hip arthroplasty.

Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

| Prescription Use | X | AND/OR |
|-----------------------------|------------------------|--------|
| (Part 21 CFR 801 Subpart D) | Over-The-Counter Use | |
| | (21 CFR 807 Subpart C) | |

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