PALACOS MV

{0}------------------------------------------------ September 17, 2018 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue letters. Heraeus Medical GmbH Ute Greiner Head of Regulatory Affairs Philipp-Reis-Straße 8/13 Wehrheim, Germany 61273 Re: K182260 Trade/Device Name: PALACOS® MV Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: August 17, 2018 Received: August 21, 2018 Dear Ute Greiner: We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Laurence D. Coyne -S For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. # Indications for Use 510(k) Number (if known) K182260 Device Name PALACOS® MV Indications for Use (Describe) PALACOS ® MV 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. Type of Use (Select one or both, as applicable): | <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-----------------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # PALACOS® MV Image /page/3/Picture/1 description: The image shows the logo and address of Heraeus Medical GmbH. The logo is a stylized wordmark with the company name "Heraeus" in a bold, sans-serif font. Below the logo is the company name and address, which is "Heraeus Medical GmbH, 61273 Wehrheim, Germany." ### Radiopaque bone cement # 510(k) Summary - K182260 | Date of summary | August 17th, 2018 | |-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device trade name | PALACOS® MV (previously named PALAMED®) | | Common name | PMMA Bone Cement | | Classification | PMMA Bone Cement : Class II Special Controls per<br>21 CFR 888.3027 | | Classification name | Polymethylmethacrylate (PMMA) bone cement | | Device product code | LOD | | Identification of the<br>marketed device to which<br>equivalence is claimed | Palamed®, K030904 (now named PALACOS® MV) | | Contact person | Ute Greiner<br>Phone: + 49 (0) 6181.35-2808<br>Fax: + 49 (0) 6181.35-2947<br>Regulatory_HM@heraeus.com | | Description of the device | PALACOS® MV 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. It is<br>currently marketed in a 44 g packaging size in the<br>United States. | | Indications for use | PALACOS® MV is intended for use in arthroplastic<br>procedures of the hip, knee, and other joints for the<br>fixation of polymer or metallic prosthetic implants<br>to living bone. | | Comparison of<br>technological<br>characteristics | Bone cement is derived by mixing a powder<br>component and a monomer liquid. The only<br>difference between the subject and predicate device<br>is the modification of the lower specification limit of the | | | benzoyl peroxide (BPO) content in the powder<br>component of the finished device. | | Discussion of preclinical<br>tests | The doughing time, maximum temperature, setting<br>time, intrusion, compressive strength, bending<br>modulus and 4-point bending strength of<br>PALACOS® MV with a lower specification limit of<br>benzoyl peroxide (BPO) content was characterized<br>per ISO 5833. In addition, impact and bending<br>strength were measured according to Dynstat test<br>method. Stability/shelf life data were also<br>compared between the subject and predicate<br>devices.<br>Bacterial endotoxin have been evaluated using<br>bacterial endotoxin test method (LAL test; known<br>as the Limulus amebocyte lysate test), in<br>accordance with the ANSI/AAMI ST72:2011. Test<br>results met the endotoxin limits for the BET: 20<br>endotoxin units (EU)/Device. | | Clinical performance data | No clinical data was provided. | | Conclusions from<br>preclinical and clinical data | PALACOS® MV with a lower limit of benzoyl peroxide<br>(BPO) content is substantially equivalent to the<br>Palamed® predicate device and meets ISO 5833<br>and Heraeus final test requirements | | Applicant's name and<br>address | Heraeus Medical GmbH<br>Philipp-Reis-Straße 8/13<br>61273 Wehrheim<br>Germany | Page 1 of 2 {4}------------------------------------------------ # PALACOS® MV Image /page/4/Picture/1 description: The image shows the logo for Heraeus Medical GmbH, located in 61273 Wehrheim, Germany. The logo is in a bold, sans-serif font and is stacked on top of the company name and address. The text is black and the background is white. ### Radiopaque bone cement # 510(k) Summary - K182260