← Product Code [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD) · K030904 # PALAMED (K030904) _Heraeus Medical GmbH Technology · LOD · Sep 23, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K030904 ## Device Facts - **Applicant:** Heraeus Medical GmbH Technology - **Product Code:** [LOD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD.md) - **Decision Date:** Sep 23, 2003 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 888.3027 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Palamed* 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. ## Device Story Palamed is an acrylic bone cement used in orthopedic surgery; composed of powder and liquid components. Device functions via exothermic polymerization to secure fixation of grafted artificial joints to living bone; improves force transfer at the implant-bone interface. Used by surgeons in clinical settings during arthroplastic procedures. ## Technological Characteristics Acrylic bone cement; PMMA-based; exothermic polymerization curing process. Class II device (21 CFR 888.3027). ## Regulatory Identification Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device 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. ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.” ## Predicate Devices - PALAMED® ([K010586](/device/K010586.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ #### (גוויר מחום מחום חשובות מחו ## SEP 2 3 2003 Image /page/0/Picture/3 description: The image shows the word "Heraeus" in a bold, sans-serif font. Below the word "Heraeus" is the alphanumeric code "K030904" in a handwritten-style font. The text is black against a white background. The image appears to be a label or identifier. ### 510(k) Summary | Applicant's name and address | Heraeus Kulzer GmbH & Co. KG
Grüner Weg 11
D-63450 Hanau | |-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact persons | Dr. K.-D. Kühn
phone: +49 6081 959-264
fax: +49 6081 959-288
klaus-dieter.kuehn@heraeus.com

Dr. C. Tuchscherer
phone: +49 6081 959-278
fax: +49 6081 959-288
christian.tuchscherer@heraeus.com | | Date of summary | March 19th, 2003 | | Device trade name | PALAMED® | | Classification name | Bone Cement | | Identification of the marketed device Palamed® to
which equivalence is claimed | PALAMED®
510k (Merck) K010586 | | Description of the device | Palamed® is an acrylic bone cement for use in
orthopedic surgery. It is formed from powder and
liquid by exothermic polymerization. It secures the
fixation of the grafted artificial joint improving the
transfer of forces at the interface implant - bone. | | Intended use | Fixation of prostheses in the bone (partial or total
hip joint replacement at the hip, knee or other
joints). | | Comparison of technological characteristics | This is the already known Palamed® marketed by
Merck. | Image /page/0/Picture/7 description: The image contains the text "Heraeus Kulzer" stacked on top of each other. The text is in a serif font and is white against a black background. The word "Heraeus" is on top, and "Kulzer" is below it. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of a bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text that reads "INSTITUTE OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the perimeter of the circle. Public Health Service SEP 2 3 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. K. D. Kühn Head of Department Heraeus Kulzer GmbH & Co. KG Grüner Weg 11 Hanau, Germany D-63450 Re: K030904 Trade/Device Name: PALAMED® Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 25, 2003 Received: July 14, 2003 Dear Dr. Kühn: 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. {2}------------------------------------------------ Page 2 - Dr. K. D. Kühn 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 Office of Compliance at (301) 594-4659. 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, Sincerely yours, Mark N. Milkman 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}------------------------------------------------ Palamed® # ાડ #### Intended Use ·· Palamed* 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. Mark N. Milliman (Division Sign-Off) Division of General, Restorative and Neurological Devices K030904 510(k) Number ________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K030904](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LOD/K030904) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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