PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G

{0}------------------------------------------------ November 23, 2020 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 features a stylized eagle. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Heraeus Medical GmbH Yannick Hermanns Manager Regulatory Affairs Philipp-Reis-Str. 8/13 Wehrheim. Hessen 61273 Germany Re: K202475 Trade/Device Name: PALACOS® R. PALACOS® R pro, PALACOS® R+G. PALACOS® R+G pro. PALACOS® MV+G Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, MBB, KIH, JDZ Dated: August 14, 2020 Received: August 28, 2020 Dear Dr. Hermanns: 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. 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 {1}------------------------------------------------ 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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font, and it is in gray. Below the word "Heraeus" is the text "Heraeus Medical GmbH" in a smaller, bold, sans-serif font, and it is in black. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. | 510(k) Number (if known) | K202475 | |--------------------------|---------| | Device Name | | PALACOS® R Indications for Use (Describe) PALACOS® R is indicated 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) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (201) 443-6740 EF {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a larger, bold font on the top line. Below it, in a smaller font, is the text "Heraeus Medical GmbH". The logo is in grayscale. K202475 Device Name PALACOS® R pro Indications for Use (Describe) PALACOS® R pro is indicated 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) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (701) 443-6740 EF {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is written in a bold, sans-serif font in gray color. Below the word "Heraeus", the words "Heraeus Medical GmbH" are written in a smaller, black, sans-serif font. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ### Indications for Use 510(k) Number (if known) K202475 Device Name PALACOS® R+G Indications for Use (Describe) PALACOS® R+G is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (201)-443-6740 EF {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is written in a large, bold, sans-serif font in gray color. Below the word "Heraeus", the words "Heraeus Medical GmbH" are written in a smaller, black, sans-serif font. | DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |-----------------------------------------|----------------------------------| | Food and Drug Administration | Expiration Date: 06/30/2020 | | Indications for Use | See PRA Statement below. | | 510(k) Number (if known) | K202475 | Device Name PALACOS® R+G pro Indications for Use (Describe) PALACOS® R+G pro is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." FORM FDA 3881 (7/17) {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is written in a large, bold, sans-serif font in gray color. Below it, in a smaller, bold, sans-serif font, is the text "Heraeus Medical GmbH" in black color. ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K202475 Device Name PALACOS® MV+G Indications for Use (Describe) PALACOS® MV+G is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." FORM FDA 3881 (7/17) {7}------------------------------------------------ 7 Image /page/7/Picture/2 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font in gray. Below it, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH". 510(k) Summary Traditional 510(k) Premarket Notification | I.<br>SUBMITTER | | |----------------------------|--------------------------------------------------| | Manufacturer: | Heraeus Medical GmbH | | | Philipp-Reis-Str. 8/13 | | | 61273 Wehrheim | | | Germany | | Contact Person: | Dr. Yannick Nils Hermanns | | | Manager Regulatory Affairs | | | Phone: +49 (6181) 35-2818 | | | Email: yannicknils.hermanns@heraeus.com | | Additional Contact Person: | Dr. Heike Gustke | | | Senior Manager Regulatory Affairs | | | Phone: +49 (6181) 35-2942 | | | Email: heike.gustke@heraeus.com | | Date Prepared: | November 9, 2020 | | II.<br>DEVICES | | | Name of Device: | PALACOS® R | | | PALACOS® R pro | | | PALACOS® R+G | | | PALACOS® R+G pro | | | PALACOS® MV+G | | Common Name: | Polymethylmethacrylate (PMMA) bone cement | | Classification Name: | Bone cement (21 CFR 888.3027): | | | PALACOS® R pro, PALACOS® R | | | Bone cement, antibiotic (21 CFR 888.3027): | | | PALACOS® R+G pro, PALACOS® R+G, PALACOS®<br>MV+G | | Regulatory Class: | Class II | | Product Code: | LOD | | | PALACOS® R pro, PALACOS® R | {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, sans-serif font and is gray in color. Below it, "Heraeus Medical GmbH" is written in a smaller, black, sans-serif font. ## MBB PALACOS® R+G pro, PALACOS® R+G, PALACOS® MV+G KIH, JDZ Subsequent Product Code(s): #### . PREDICATE DEVICES PALACOS® R (K030902) PALACOS® R pro (K150119) PALACOS® G (K031673) PALACOS® R+G pro (K142157) PALAMED G (K050855) No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION A bundled Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to PALACOS® R, PALACOS® R pro, PALACOS® R+G, PALACOS® R+G pro, and PALACOS® MV+G previously cleared in K030902, K150119, K031673, K142157 and K050855. Modifications include changes of instructions for use (IFU) and labels as well as the addition of MRI safety information. This submission encompasses multiple devices that have similar intended use and indications for use as well as relv on similar data. ## PALACOS® bone cements without Gentamicin PALACOS® R and PALACOS® R pro are polymethylmethacrylate (PMMA) bone cements: - PALACOS® R: is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery. - -PALACOS® R pro: is a PMMA based PALACOS® R bone cement, packed in a closed mixing and application system ready for processing (ready-to-mix) The bone cements consist of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, and initiator. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration). ## PALACOS® bone cements with Gentamicin PALACOS® R+G, PALACOS® R+G pro and PALACOS® MV+G are PMMA bone cements, containing the antibiotic Gentamicin: - -PALACOS® R+G (previously cleared under the name PALACOS® G); is a standard-setting. high-viscosity, PMMA-based bone cement for orthopaedic surgery, {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in large, bold, sans-serif font. Below it, in a smaller font size, are the words "Heraeus Medical GmbH". - PALACOS® R+G pro is a PMMA based PALACOS® R+G bone cement, packed in a closed mixing and application system ready for processing (ready-to-mix) and - PALACOS® MV+G (previously cleared under the name PALAMED G) is a standard-setting, medium-viscosity, radiopaque, poly(methyl methacrylate)-based bone cement for orthopaedic surgery. The bone cements consist of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, initiator and the antibiotic Gentamicin. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration). #### V. INTENDED USE ## PALACOS® R PALACOS® R is a PMMA bone cement 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. ## PALACOS® R pro PALACOS® R pro is a PMMA bone cement 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. ## PALACOS® R+G PALACOS® R+G is a PMMA bone cement intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic implants to living bone. # PALACOS® R+G pro PALACOS® R+G pro is a PMMA bone cement 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. ## PALACOS® MV+G PALACOS® MV+G is a PMMA bone cement 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. #### VI. INDICATIONS FOR USE ## PALACOS® R PALACOS® R is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, sans-serif font and is gray in color. Below it, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH". # PALACOS® R pro PALACOS® R pro is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. # PALACOS® R+G PALACOS® R+G is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. # PALACOS® R+G pro PALACOS® R+G pro is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. # PALACOS® MV+G PALACOS® MV+G is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VII. DEVICE # PALACOS® R Device comparison demonstrated that the PALACOS® R is substantially equivalent to the previously cleared PALACOS® R (K030902) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle. At a high level, the subject device and predicate device are based on the following same technological elements: - -PMMA bone cement, - -Chemical composition, - -Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135-1 and DIN EN ISO 10993-7 - Mechanical characteristics as per ISO 5833 and ASTM F451, - - -Mixing and application properties, and - Clinical use of the devices including the anatomical location, duration of exposure, and intended use population. # PALACOS® R pro Device comparison demonstrated that the PALACOS® R pro is substantially equivalent to the previously cleared PALACOS® R pro (K150119) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle. At a high level, the subject device and predicate device are based on the following same technological elements: - -PMMA bone cement, - -Chemical composition, {11}------------------------------------------------ Image /page/11/Picture/2 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font. Below it, in a smaller font, are the words "Heraeus Medical GmbH". The logo is in grayscale. - Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135-1 and DIN EN ISO 10993-7 - Mechanical characteristics as per ISO 5833 and ASTM F451, - - -Mixing and application properties, and - Clinical use of the devices including the anatomical location, duration of exposure, and intended use population. # PALACOS® R+G Device comparison demonstrated that the PALACOS® R+G is substantially equivalent to the previously cleared PALACOS® G (K031673) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle. At a high level, the subiect device and predicate device are based on the following same technological elements: - PMMA bone cement, - - Chemical composition, - - -Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135-1 and DIN EN ISO 10993-7 - Mechanical characteristics as per ISO 5833 and ASTM F451, - - -Mixing and application properties, and - Clinical use of the devices including the anatomical location, duration of exposure, and intended use population. ## PALACOS® R+G pro Device comparison demonstrated that the PALACOS® R+G pro is substantially equivalent to the previously cleared PALACOS® R+G pro (K142157) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle. At a high level, the subject device and predicate device are based on the following same technological elements: - PMMA bone cement, - - -Chemical composition, - -Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135-1 and DIN EN ISO 10993-7 - Mechanical characteristics as per ISO 5833 and ASTM F451, - - -Mixing and application properties, and - Clinical use of the devices including the anatomical location, duration of exposure, and intended use population. ## PALACOS® MV+G Device comparison demonstrated that the PALACOS® MV+G is substantially equivalent to the previously cleared PALAMED® G (K050855) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle. At a high level, the subject device and predicate device are based on the following same technological elements: - PMMA bone cement, - - -Chemical composition, - -Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135-1 and DIN EN ISO 10993-7 - Mechanical characteristics as per ISO 5833 and ASTM F451, - {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the title of a document. The title is "Traditional 510(k) Premarket Notification". Underneath that is the text "PALACOS® Bone Cements". Image /page/12/Picture/2 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in large, gray, sans-serif font on the top line. Below that, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH". - Mixing and application properties, and - -Clinical use of the devices including the anatomical location, duration of exposure, and intended use population #### PERFORMANCE DATA VIII. The submitter of this Traditional 510(k) Premarket Notification is the manufacturer of the predicate devices. ## PALACOS® bone cements without Gentamicin A risk-based assessment was performed as per DIN EN ISO 14971 to evaluate the impact of the modifications to the labelling of the PALACOS® R and PALACOS® R pro. The modified IFUs do not alter the previously validated packaging or sterilization data as well as the existing results of non-clinical performance testing and biocompatibility in accordance with the FDA Class II Special Controls Guidance Document 'PMMA Bone Cement'. The risk-based assessment concludes that the IFU changes do not significantly affect the device's risk profile because no new risks or significantly modified existing risks are identifically based rationale has been prepared to designate the bone cements as "MR Safe". PALACOS® R and PALACOS® R pro are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic and pose no known hazards in all MR environments. Shelf life and pyrogenicity of PALACOS® R and PALACOS® R pro remain unchanged and testing are intended to be leveraged from their previous clearances in accordance with 21 CFR 807.92(b)(1). It has been demonstrated that the subject devices are as safe and effective as the predicate devices (K150119, K030902). ## PALACOS® bone cements with Gentamicin A risk-based assessment was performed as per DIN EN ISO 14971 to evaluate the impact of the modifications to the labelling of the PALACOS® R+G, PALACOS® R+G pro and PALACOS® MV+G. The modified IFUs do not alter the previously validated packaging or sterilization data as well as the existing results of non-clinical performance testing and biocompatibility in accordance with the Class II Special Controls Guidance Document 'PMMA Bone Cement'. The risk-based assessment concludes that the IFU changes do not significantly affect the device's risk profile because no new risks or significantly modified existing risks are identifically based rationale has been prepared to designate the bone cements as "MR Safe". PALACOS® R+G, PALACOS® R+G pro and PALACOS® MV+G are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic and pose no known hazards in all MR environments. Shelf life and pyrogenicity of PALACOS® R+G, PALACOS® R+G pro and PALACOS® MV+G pro remain unchanged and testing are intended to be leveraged from their previous clearances in accordance with 21 CFR 807.92(b)(1). It has been demonstrated that the subject devices are as safe and effective as the predicate devices (K031673, K142157, K050855). #### CLINICAL TESTING IX. ## PALACOS® R No clinical testing of the PALACOS® R has been conducted. ## PALACOS® R pro {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font and is gray in color. Below it, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH". K202475 Page 7 of 7 No clinical testing of the PALACOS® R pro has been conducted. ## PALACOS® R+G No clinical testing of the PALACOS® R+G has been conducted. ## PALACOS® R+G pro No clinical testing of the PALACOS® R+G pro has been conducted. ## PALACOS® MV+G No clinical testing of the PALACOS® MV+G has been conducted. #### X. CONCLUSIONS ## PALACOS® R The PALACOS® R is substantially equivalent to the predicate device (PALACOS® R., K030902) identified in this premarket notification. ## PALACOS® R pro The PALACOS® R pro is substantially equivalent to the predicate device (PALACOS® R pro, K150119) identified in this premarket notification. ## PALACOS® R+G The PALACOS® R+G is substantially equivalent to the predicate device (PALACOS® G, K031673) identified in this premarket notification. ## PALACOS® R+G pro The PALACOS® R+G pro is substantially equivalent to the predicate device (PALACOS® R+G pro, K142157) identified in this premarket notification. ## PALACOS® MV+G The PALACOS® MV+G is substantially equivalent to the predicate device (PALAMED® G, K050855) identified in this premarket notification.