Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top. Inside the circle is a stylized image of a human figure, with three overlapping profiles facing to the right. The profiles are connected by a flowing line that resembles a ribbon or wave. JAN 2 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Sam Son Vice President Technical Affairs Osteoimplant Technology, Inc. 11201 Pepper Road Hunt Valley, Maryland 21031 Re: K040685 Trade/Device Name: Z-Series Modular Total Hip System Plasma Coated Regulation Numbers: 21 CFR 888.3350; 21 CFR 888.3353; 21 CFR 888.3360; 21 CFR 888.3390 Regulation Names: Hip joint metal/polymer semi-constrained cemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis; Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Codes: JDI; LZO; LWJ; KWL; KWY Dated: November 22, 2004 Received: November 24, 2004 Dear Mr. Son: 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. {1}------------------------------------------------ ## Page 2 - Mr. Sam Son Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 Of to rate of 77 mores (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. 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 promated 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark A. Milken 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 {2}------------------------------------------------ Page 1 of 1 510(k) Number (if known) K040685 Device Name: Z™ - Series Modular Total Hip System Plasma Coated Indications For Use: The Z™ - Series Modular Total Hip System Plasma Coated is indicated for use in total or partial THE Z - - Series Modular Total Thp Dystants suffering severe pain and disability due to structural mp repacctions probocare on theumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the ulsoucis, a vasouiar noorosis, acaimis with congenital hip dysplasia, protrusio acetabuli, slipped prosulests is also manufacture due to previous fusion, where bone stock is inadequate for other reconstruction techniques. CP Titanium Plasma Coated Implants are intended for Cement or Press Fit Applications. Prescription Use (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) Mark N. Millhiser Division of General. Restorative. and Neurological Devic K040685 (106) Member