CraniUS Plate

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 11, 2029 CraniUS, LLC Oxana Pantchenko Regulatory Consultant 1700 Union Ave., Suite A1 Baltimore, Maryland 21211 Re: K262874 Trade/Device Name: CraniUS Plate Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO Dated: August 14, 2026 Received: August 14, 2026 Dear Oxana Pantchenko: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262874 - Oxana Pantchenko Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K262874 - Oxana Pantchenko Page 3 Sincerely, JULIA E. SLOCOMB -S Digitally signed by JULIA E. SLOCOMB -S Date: 2026.09.11 12:35:01 -04'00' for Jaime Raben, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | ? | | Please provide the device trade name(s). | | ? | | CraniUS Plate | | | | Please provide your Indications for Use below. | | ? | | The CraniUS Plate is indicated for use to fill a bony void or defect areas in a cranial skeleton. | | | | Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} K262874, Page 1 of 3 # **510(k) Summary** Date Prepared: August 14, 2026 # **Manufacturer and 510(k) Owner** CraniUS, LLC 1700 Union Avenue, Suite A1 Baltimore, MD 21211 Official Contact: Sachin Thanawala, VP, Quality and Regulatory # **Representative/Consultant** Oxana S. Pantchenko Ph.D. (650)269-4915 Oxana@MedicalDeviceConsulting.US # **Device Information** Name: CraniUS Plate Regulation Number: 21 CFR 882.5320 - Preformed alterable cranioplasty plate Class: II Product Code: GWO – Plate, Cranioplasty, Preformed, Alterable Medical Specialty: Neurology # **Predicate/Device Identification** K261058 CraniUS Plate # **Device Description** The CraniUS Plate is indicated for use to fill a bony void or defect areas in a patient’s specific cranial skeleton. The implant is attached to the bone using FDA cleared cranial fixation screws and plates. The device is machined from Polyether Ether Ketone (PEEK) material. The CraniUS Plate may contain convenience features requested by surgeons: perfusion / suture holes, cut-backs, through-holes, and/or openings for an implantable reservoir and/or a sensor. Implantable reservoirs and sensors are not included. The device is provided non-sterile. The CraniUS Plate is a prescription-only device. # **Indications for Use** The CraniUS Plate is indicated for use to fill a bony void or defect areas in a cranial skeleton. # **Comparison of Technological Characteristics** The subject device, the CraniUS Plate, has the same indications for use, technology, and material compared to the predicate device. More specifically, both implants are indicated to fill a bony void or defect area in a patient’s specific cranial skeleton and are both made from the same material. Both devices are provided clean but not sterile. The implant size range and thickness are identical to the predicate device. The predicate CraniUS Plate may have the following features: perfusion holes, temporal cutback, and an opening for an implantable reservoir. The subject device may have the same set of features, as well as an additional opening feature for an implantable intracranial pressure sensor. The feature consists of a pattern of holes. Each hole has similar characteristics as those cleared in K261058. This feature will be offered as an additional customization option to be added to the implant per surgeon’s request. While minor dimensional differences are present between the two devices, they do not alter the indications for use of the subject device. Minor dimensional differences along with successfully performed mechanical testing do not affect the safety and effectiveness of the subject device, nor do they raise any new or novel safety or effectiveness questions from those raised by the predicate device. {5} K262874, Page 2 of 3 Please see the device comparison table for additional details. | | Subject Device | Predicate | | --- | --- | --- | | Device Name | CraniUS Plate | CraniUS Plate | | 510(k) clearance | K262874 | K261058 | | Regulation | 21 CFR 882.5320 | 21 CFR 882.5320 | | Product Class | II | II | | Product Code | GWO | GWO | | Intended Use | The CraniUS Plate is indicated for use to fill a bony void or defect areas in a cranial skeleton. | The CraniUS Plate is indicated for use to fill a bony void or defect areas in a cranial skeleton. | | Population | adults | adults | | Material | Evonik Vestakeep i4 | Evonik Vestakeep i4 | | Technical Specification | Customized skull implant | Customized skull implant | | Sterilization | Provided non-sterile | Provided non-sterile | | Implant size | 25 mm to 250 mm wide, 25 mm to 250 mm long | 25mm to 250 mm wide, 25 mm to 250mm long | | Implant thickness | 2 mm to 10 mm | 2 mm to 10 mm | | Features | Perfusion/suture holes, temporal cutback, and/or openings for an implantable reservoir and/or a sensor. | Perfusion/suture holes, temporal cutback, openings for an implantable reservoir. | ### Summary of Non-Clinical Testing: #### Biocompatibility Testing: The CraniUS Plate is categorized as a long term (> 30days) implant in direct contact with tissue/ bone, neural tissue and CSF. The following biocompatibility endpoints were assessed on the final, finished, sterilized device and it was determined that no additional testing was needed: cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subchronic systemic toxicity, chronic systemic toxicity, hemocompatibility (indirect hemolysis test), genotoxicity, neurotoxicity, implantation, and carcinogenicity. #### Cleaning and Sterilization Testing: Sterilization validation was assessed on the final, finished, sterilized device and it was concluded that the subject device had no impact on the predicate sterilization validation. The Bacterial Endotoxins Test was successfully completed. This testing was conducted in accordance with the following regulatory documents: ANSI/AAMI ST72:2019, ISO 11737-3:2023, USP <161>, USP <85>, EP 2.6.14, and JP 4.01. #### Mechanical Testing: A mechanical testing verification protocol was developed where the performance characteristics were compared to those of the predicate device. All mechanical testing was conducted at a 3 \( ^{rd} \) party accredited testing laboratory. {6} K262874, Page 3 of 3 # **MR Safety:** The CraniUS Plate is electrically nonconductive or a nonmagnetic item and poses no known hazards in all MR environments. The CraniUS Plate implants are MR Safe. # **Summary of Clinical Testing:** Clinical testing was determined not applicable for the CraniUS Plate. # **Conclusion** The subject device utilizes the same intended use, same material composition, and similar technological characteristics as the predicate device such that the CraniUS Plate does not raise new issues of safety or effectiveness when compared to the predicate device. The non-clinical laboratory data indicate that the subject device is as safe, as effective, and performs as well as the predicate device and support a finding of substantial equivalence.