DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the word "zimmer" with a stylized "Z" in a circle to the left of the word. The "Z" is black and bolded, while the word "zimmer" is in a smaller, sans-serif font. The circle around the "Z" is dashed. The image is in black and white. 1/2 ## 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: (574) 372-4523<br>Fax: (574) 372-4605 | | 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). | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The font is sans-serif and the color is black. 。 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in all capital letters. 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 {3}------------------------------------------------ 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 (800) 638-2041 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 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Zimmer company logo. The logo consists of a stylized letter "Z" inside a circle, followed by the word "zimmer" in a sans-serif font. The letter "Z" and the word "zimmer" are both in black, while the circle is white with a black outline. The logo is simple and modern, and it is likely used to represent the Zimmer company in its branding and marketing materials. ## 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) | | (Please do not write below this line if another page if needed) Division Sign-Off Concurrence of CDRH, Office of General, Restorative (ODE) and Neurological Devices the text is not well formatted and the table structure is incorrect. The phrase "Division Sign-Off" is not correctly captured. The phrase "Division of General, Restorative and Neurological Devices" is not correctly captured. The 510(k) number is not correctly captured. There are some OCR errors too. The table structure is not correct. The labels and values are not correctly aligned. The html code is not well formatted. 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