PALABOND

{0}------------------------------------------------ ## ADDreviated JTV(K) Palabond® .FEB 2 6 2003 Image /page/0/Picture/3 description: The image shows the word "Heraeus" in a bold, sans-serif font. The letters are black and stand out against a white background. The word is presented in a straightforward, unadorned manner, emphasizing its clarity and readability. The overall impression is one of simplicity and directness. ## 510(k) Summary 022251 page 1 of 1 | Applicant's name and address | Heraeus Kulzer GmbH & Co. KG<br>Grüner Weg 11<br>D-63450 Hanau | |-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact persons | Dr. K.-D. Kühn<br>phone: +49 6081 959-264<br>fax: +49 6081 959-288<br>klaus-dieter.kuehn@heraeus.com | | | Dr. C. Tuchscherer<br>phone: +49 6081 959-278<br>fax: +49 6081 959-288<br>christian.tuchscherer@heraeus.com | | Date of summary | 28.5.2002 | | Device trade name | PALABOND® | | Classification name | Bone Cement | | Identification of the marketed device Palacos® to<br>which equivalence is claimed | PALACOS® R BONE CEMENT<br>PMA Number: P810020 | | Description of the device | Palabond® is an acrylic bone cement for use in<br>orthopedic surgery. It is formed from powder and<br>liquid by exothermic polymerization. It secures the<br>fixation of the grafted artificial joint improving the<br>transfer of forces at the interface implant-bone. | | Intended use | Fixation of prostheses in the bone (partial or total<br>hip joint replacement at the hip, knee or other<br>joints). | | Comparison of technological characteristics | Palabond® is chemically identical to the well<br>known Palacos® R being marketed for more than<br>25 years implicating the same biocompatibility.<br>The only difference is the addition of bigger<br>particles (granules) of copolymer to the powder.<br>The mechanical performance is equivalent (see test<br>report). | Heraeus Kulzer GmbH & Co. KG, KULZER:, Bereich Medizin, Dr. Klaus-Dieter Kühn Image /page/0/Picture/8 description: The image shows the words "Heraeus Kulzer" stacked on top of each other. The text is white and the background is black. The font is a serif typeface. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 6 2003 Dr. K.D. Kuhn Heraeus Kulzer GmbH & Co. KG Gruner Weg 11 D-63450 Hanau Re: K022251 Trade Name: Palabond Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: December 12, 2002 Received: December 16, 2002 Dear Dr. K.D. Kuhn: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. {2}------------------------------------------------ ## Page 2 - Dr. K.D. Kuhn 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 McMullen 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 {3}------------------------------------------------ Page 1 of 1 510(k) Number (if known): K022251 Device Name: PALABOND® Indications For Use: PALABOND is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) for Martha N. Milliken ivision A Carano Restorative and Neurological Number Koadas (Optional Format 3-10-98)