mb-FIX Cranial Stabilization Systems

{0} FDA U.S. FOOD & DRUG ADMINISTRATION November 6, 2025 Medical Bees GmbH % Angelika Scherp Regulatory Affairs Consultant Business Support International Aalsmeerweg 123-3 Amsterdam, NH 1059AH Netherlands Re: K250423 Trade/Device Name: mb-FIX Cranial Stabilization Systems Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: October 10, 2025 Received: October 10, 2025 Dear Angelika Scherp: 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} K250423 - Angelika Scherp 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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} K250423 - Angelika Scherp Page 3 Sincerely, Adam D. Pierce -S Digitally signed by Adam D. Pierce -S Date: 2025.11.06 08:32:13 -05'00' Adam D. Pierce, Ph.D. Assistant 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} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K250423 | | | Device Name mb-FIX Cranial Stabilization Systems | | | Indications for Use (Describe) The mb-FIX Cranial Stabilization System Skull Clamps (Gold Standard Head Holding System, Premium Head Holding System and CT/MRI-compatible Head Holding System) are placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamps and pins are indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The CT/MRI-compatible model and the Titanium or PEEK + Titanium Skull Pins are used when intra-operative imaging is required. The mb-FIX Cranial Stabilization System provides an interface for accessories like retractor systems or navigation adaptors or other items. | | | 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." | | {4} K250423 Page 1 of 5 # 510(K) Summary Date: November 4, 2025 | Submitter: | Name: | Medical Bees GmbH | | --- | --- | --- | | | Address: | Friedrich-Woehler-Strasse 13, 78576 Emmingen-Liptingen, Germany | | | Contact Person: | Reinhold Bücher Senior Manager Quality Management and Regulatory Affairs | | | Email: | ra@medical-bees.de | | Product: | Name of Device: | mb-FIX Cranial Stabilization System | | | Classification: | HBL Skull Clamp, Reg. No. 882.4460 | | | | HBM Neurosurgical Headrest, Reg. No. 882.4440 | | Predicate Devices: | K142238 | Mayfield Skull Clamp | | | K072208 | MAYFIELD Disposable and Reusable Titanium Skull Pins | | Reference Devices: | K191740 | DORO LUCENT iXI and iMRI Headrest System | | | K941558 | Mayfield Disposable Stainless Steel Pin (Child) | | | K193438 | DORO Disposable Skull Pin Pediatric | | | K163322 | TZ Skull Pin Adult | Device Description: mb-FIX Cranial Stabilization Systems include three models of skull clamp: - Gold Standard Head Holding System - Premium Head Holding System - CT/MRI-compatible Head Holding System Each Head Holding System consists of a skull clamp and a base unit permitting attachment to an operating table. The device includes four skull pin models, each provided in two sizes, one for adults and one for children. The skull pins are manufactured of stainless steel, titanium, PEEK + stainless steel or PEEK + titanium. The skull pins containing stainless steel are MR Unsafe devices. The skull pins manufactured of titanium or of PEEK + titanium are MR Conditional devices The CT/MRI-compatible Head Holding System is MR Safe and can be used in combination with the titanium or PEEK + titanium skull pins when intra-operative imaging is required. The Gold Standard and Premium Head Holding Systems are MR Unsafe. The mb-FIX Cranial Stabilization System provides an interface for accessories like retractor systems, navigation adaptors or other items. Indications for Use: The mb-FIX Cranial Stabilization System Skull Clamps (Gold Standard Head Holding System, Premium Head Holding System and CT/MRI-compatible Head Holding System) are placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamps and pins are indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The CT/MRI-compatible model and the Titanium or PEEK + Titanium Skull Pins are used when intra-operative imaging is required. The mb-FIX Cranial Stabilization System provides an interface for accessories like retractor systems, navigation adaptors or other items. {5} K250423 Page 2 of 5 The technological characteristics: The technological and performance characteristics of the subject device are the same as those of the predicate devices, as shown by the following summary table: Technological Characteristics: | | Subject Device | Predicate Device | | --- | --- | --- | | Manufacturer | Medical Bees GmbH | Integra LifeSciences Corporation | | Product Name | mb-FIX Cranial Stabilization Systems Skull Clamps | Mayfield Skull Clamp | | Common Name | Skull Clamp | Skull Clamp | | Classification Regulation | 882.4460 | 882.4460 | | 510(k) Number | K250423 | K142238 | | Indications for Use | The mb-FIX Cranial Stabilization System Skull Clamps (Gold Standard Head Holding System, Premium Head Holding System and CT/MRI- compatible Head Holding System) are placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamps and pins are indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The CT/MRI-compatible model and the Titanium or PEEK + Titanium Skull Pins are used when intra-operative imaging is required. The mb-FIX Cranial Stabilization System provides an interface for accessories like retractor systems, navigation adaptors or other items. | The MAYFIELD Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. | | Design and Operating principle | The mb-FIX Cranial Stabilization System Skull Clamps are a cranial stabilization device, designed to provide rigid skeletal fixation. The mb-FIX Cranial Stabilization System Skull Clamps support a 2-pin rocker arm, which allows for 360° rotation under full impingement force. The device has the means for skull pin force determination via an integral force gauge in the torque screw opposite the rocker arm. The device is equipped with an adjustable arm to allow the surgeon to adjust the clamp for various head sizes. The mb-FIX Cranial Stabilization System Skull Clamps do not directly contact the patient. The skull pins used with the skull clamp are the components which contact | Same. The Skull Pins are not included in K142238. | {6} K250423 Page 3 of 5 | | the patient. The skull pins are included this 510(k). | | | --- | --- | --- | | Type of head fixation | Three-point fixation | Three-point fixation | | General Shape | “U” shape | Parallelogram | | Clamping force | 80 lbs | 80 lbs | | Interface for accessories | Yes | Yes | | Imaging modality | Gold Standard and Premium Head Holding System • -None CT/MRI-compatible Head Holding System • CT- and MR-imaging | None | | Sterility | Non-sterile | Non-sterile | | Reprocessing | Automatic cleaning and disinfection between uses, steam sterilization possible | Manual or automatic cleaning and disinfection between uses | | Materials | Gold Standard Head Holding System • Cast aluminum, stainless steel, gold plating Premium Head Holding System • Cast aluminum, stainless steel, gold plating, proprietary coating CT/MRI-compatible Head Holding System • PEEK, POM C | PEEK / Glass fiber composite Radel R (Polyphenylsulphone) Teflon, Hastelloy, stainless steel, silicone | | Maquet Table Base Unit | Available for CT/MRI-compatible Head Holding System | No | | Provides an interface for accessories like retractor systems, navigation adaptors or other items | Yes | Yes | | | Subject Device | Predicate Device | | Manufacturer | Medical Bees Gmbh | Integra LifeSciences Corporation | | Product Name | mb-FIX Cranial Stabilization Systems Skull Pins | MAYFIELD Disposable and Reusable Titanium Skull Pins | | Common Name | Skull Pin | Skull Pin | | Classification Regulation | 882.4460 | 882.4460 | | 510(k) Number | K250423 | K072208 | {7} K250423 Page 4 of 5 | Indications for Use | The mb-FIX Cranial Stabilization System Skull Clamps (Gold Standard Head Holding System, Premium Head Holding System and CT/MRI- compatible Head Holding System) are placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamps and pins are indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary. The CT/MRI-compatible model and the Titanium or PEEK + Titanium Skull Pins are used when intra-operative imaging is required. The mb-FIX Cranial Stabilization System provides an interface for accessories like retractor systems, navigation adaptors or other items. | The MAYFIELD Disposable and Reusable Titanium Skull Pins are intended for use with a MAYFIELD skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative MR imaging is used. The MAYFIELD Disposable and Reusable Titanium Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative MR imaging of the patient is used. | | --- | --- | --- | | Design and Operating Principle | The mb-FIX Cranial Stabilization Systems Skull Pins are available in two sizes, Adult and Child. The pins are used with mb-FIX Cranial Stabilization Systems Skull Clamps to hold the patient's head and neck in a particular position during surgical procedures where rigid skeletal fixation is desired In preparation for surgery three Skull Pins are installed in a mb-FIX Cranial Stabilization Systems Skull Clamp. Two Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Skull Pin is inserted on the opposite side. | Same – intended for use with MAYFIELD Skull Clamps | | Recommended Age of Use | Two sizes, Adult and Pediatric The skull pin is not recommended for use on infants or children under 5 years of age. | Two sizes, Adult and Pediatric The skull pin is not recommended for use on infants or children under 5 years of age. | | Material | • Titanium or stainless steel • PEEK + titanium • PEEK + stainless steel | Titanium | | MR compatibility | • Pins manufactured from stainless steel, with or without PEEK – MR Unsafe • Pins manufactured from titanium, with or without PEEK – MR Conditional | MR Conditional | | Reusability | Reusable | Reusable | {8} K250423 Page 5 of 5 | Sterility | Non-sterile | Non-sterile | | --- | --- | --- | | Reprocessing | Automatic cleaning and disinfection followed by steam sterilization | Reusable skull pins - Manual or automatic cleaning and disinfection followed by steam sterilization | ## Performance Testing: Design verification and validation testing to support determination of substantial equivalence to the predicate consisted of the following tests: - Mechanical testing in accordance with the requirements of standard ASTM F3395/F3395M-19 Standard Specification for Neurosurgical Head Holder Devices: - Skull clamp static load test - Skull clamp load loss - Skull clamp torque load resistance test - Skull clam vertical shear test - Skull clamp force delivery accuracy verification - Skull pin shear testing to support mechanical integrity of the skull pins under loads occurring during surgical application. - MRI evaluation and MRI compatibility testing in accordance with the requirements of standards ASTM F2052-21 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment; ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment; ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance. Testing; ASTM F2119-24 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants - Reprocessing validation testing of cleaning and sterilization instructions. - Performance testing of the skull pins labeled "pediatric" to support the pediatric intended use. - Performance testing to support the Zero Move skull clamp feature. Acceptance criteria were met for all tests performed, demonstrating that the mb-FIX Cranial Stabilization Systems are substantially equivalent to the predicate devices and safe for their intended use. ## Conclusion: The subject device mb-FIX Cranial Stabilization Systems has the same intended use and technological characteristics as the predicate devices. Based on the similarities of the indications for use, technological characteristics and design verification and validation test results, the mb-FIX Cranial Stabilization Systems are substantially equivalent to the predicate devices.