iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 11, 2025 Stryker Instruments Alison Garrad Senior Staff Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002 # Re: K250374 Trade/Device Name: iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round. Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond Round, Distal Bend (8431-013-050DC); iBur 3.0mm Precision Match Head, Distal Bend (8431-107-530) Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE Dated: February 10, 2025 Received: February 10, 2025 # Dear Alison Garrad: 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. {1}------------------------------------------------ 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" (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 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-reportingcombination-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 Rue"). 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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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-device-safety/medical-device-reportingmdr-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 {2}------------------------------------------------ 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-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, Image /page/2/Picture/3 description: The image shows the text "Adam D. Pierce -S" in a large, sans-serif font. The text is arranged in two lines, with "Adam D." on the first line and "Pierce -S" on the second line. The background is a light blue color, with a faint, stylized design element behind the text. Digitally signed by Adam D. Pierce -S Date: 2025.03.11 16:37:12 -04'00' 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K250374 Device Name iBur™ Hubs and Cutting Accessories ### Indications for Use (Describe) The iBur™ Hubs and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the iBur™ Hubs and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications. Specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ Endoscopic/ Transnasal/ Transphenoidal, and Orthopedic Spine. These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | ### 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}------------------------------------------------ | Contact Details | | | | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | 510(k) Owner | Stryker Instruments<br>1941 Stryker Way,<br>Portage, MI 49002,<br>USA<br>Phone: 269 323 7700 | | | | FDA Establishment Registration No. | 3015967359 | | | | Contact Person | Alison Garrad<br>Senior Staff Regulatory Affairs Specialist<br>Phone: +353-21-4533252<br>mailto:alison.garrad@stryker.com | | | | Date Submitted | March 11, 2025 | | | | Device Name | | | | | Trade Name | Stryker iBur™ cutting accessories | | | | Common Name | Powered simple cranial drills, burrs, tre-<br>phines, and their accessories | | | | Classification | Class II | | | | Primary Classification | Drills, Burrs, Trephines & Accessories<br>(Simple, Powered)<br>(21 CFR 882.4310, Product code HBE) | | | | Secondary Classification | Drill, Surgical ENT (Electric or Pneumatic)<br>including Handpiece<br>(21 CFR 874.4250, Product code ERL) | | | | Reason for 510(k) Submission | Device modifications, no change to<br>fundamental scientific technology or<br>intended use. | | | | Device Modification | 1. Update to bend profile of cutting<br>accessory specifications to alleviate<br>contact pressure at distal tip.<br>2. Introduction of alignment<br>specification between on cutting<br>accessory distal bushing and nose<br>tube. | | | | Legally Marketed Predicate Device | | | | | 510(k) Number | Product Code | Trade Name | Manufacturer | | K210377 | HBE | Stryker iBur™ Hubs<br>and Cutting<br>Accessories | Stryker Instruments | | Reference Device | | | | | 510(k) Number | Product Code | Trade Name | Manufacturer | | TBA | HBE | Stryker iBur™ Cutting Accessories | Stryker Instruments | | | | | | | Indications for Use | | The iBur™ Hubs and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the iBur™ Hubs and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.<br><br>Specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ Endoscopic/ Transnasal/ Transphenoidal, and Orthopedic Spine.<br><br>These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices. | | | Device Description | | iBur™ Cutting Accessories are prescription medical devices that are designed to provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Endoscopic. Cutting accessories are single use, sterile devices which have a mount or notch machined at their proximal end and a head with a sharp cutting edge at their distal end. The iBur™ Cutting Accessories are designed to fit the corresponding iBur™ Hubs. The cutting accessories when used with a high speed drill and iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures. | | | Performance Data (Non-clinical Tests) | | The results of the performance testing | | {5}------------------------------------------------ {6}------------------------------------------------ | | demonstrate that the functionality, integrity,<br>and safety and effectiveness of the iBur™<br>Cutting Accessories is sufficient for their<br>intended use and support a determination<br>of substantial equivalence to the predicate<br>devices. | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Performance Testing | Risk Management was conducted in<br>accordance with ISO 14971. | | | Performance testing was conducted on<br>the proposed devices as determined by<br>the risk analysis for the products. The<br>following areas were evaluated:<br>• Temperature and Simulated Use<br>Testing<br>• Design Validation | | | Results of these tests demonstrate that<br>the functionality, integrity, and safety and<br>effectiveness of the subject devices are<br>sufficient for their intended use and support<br>a determination of substantial equivalence | | Clinical Tests | No clinical testing was deemed necessary<br>for this 510(k). | # Table 1 Device Numbers and Descriptions | Device Part Number | Device Description | |--------------------|-----------------------------------------------| | 8431-107-030D | iBur™ 3.0mm Diamond Match Head, Distal Bend | | 8431-009-030 | iBur™ 3.0mm Precision Round, Distal Bend | | 8431-009-040 | iBur™ 4.0mm Precision Round, Distal Bend | | 8431-012-020D | iBur™ 2.0mm Diamond Round, Distal Bend | | 8431-012-030D | iBur™ 3.0mm Diamond Round, Distal Bend | | 8431-012-040D | iBur™ 4.0mm Diamond Round, Distal Bend | | 8431-013-030DC | iBur™ 3.0mm Coarse Diamond Round, Distal Bend | | 8431-013-040DC | iBur™ 4.0mm Coarse Diamond Round, Distal Bend | | 8431-013-050DC | iBur™ 5.0mm Coarse Diamond Round, Distal Bend | | 8431-107-530 | iBur™ 3.0mm Precision Match Head, Distal Bend | {7}------------------------------------------------ | Table 2 Summary of Substantial Equivalence Table - Regulatory Information | | | | |---------------------------------------------------------------------------|--|--|--| |---------------------------------------------------------------------------|--|--|--| | Description | | Stryker iBur™ cutting accessories<br>[Subject] | Stryker iBur™ cutting accessories<br>[Predicate K210377] | Explanation of Difference | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | 510(k) | | TBD | K210377 | N/A | | Product Code | | HBE | HBE | Identical | | Secondary Product Code | | ERL | ERL | Identical | | Regulatory Information | Indications for Use | The iBur™ Hubs and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the iBur™ Hubs and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.<br>Specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ | The iBur™ Hubs and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the iBur™ Hubs and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.<br>Specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ | Identical | | Description | Stryker iBur™ cutting accessories<br>[Subject] | Stryker iBur™ cutting accessories<br>[Predicate K210377] | Explanation of Difference | | | | Endoscopic/ Transnasal/<br>Transphenoidal, and Orthopedic<br>Spine. | Endoscopic/ Transnasal/<br>Transphenoidal, and Orthopedic<br>Spine. | | | | | These devices are also usable in the<br>preparation for the placement of<br>screws, metal, wires, pins, and other<br>fixation devices. | These devices are also usable in the<br>preparation for the placement of<br>screws, metal, wires, pins, and other<br>fixation devices. | | | | Classification<br>of Device | Class II | Class II | Identical | | | Regulation<br>Number | 882.4310 | 882.4310 | Identical | | | Regulation<br>Name | Powered simple cranial drills, burrs,<br>trephines, and their accessories | Powered simple cranial drills, burrs,<br>trephines, and their accessories | Identical | | | Condition of<br>Use | Single use | Single use | Identical | | | Type of Use | Prescription Use Only | Prescription Use Only | Identical | | | Patient<br>Population | General | General | Identical | | | Contra-<br>indications | None Known | None Known | Identical | | {8}------------------------------------------------ {9}------------------------------------------------ | Description | | Stryker iBur™ cutting accessories [Subject] | Stryker iBur™ cutting accessories [Predicate K210377] | Explanation of Difference | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | Technological Characteristics | Attachment to Motor interface | SD/PD style interface | SD/PD style interface | Identical | | | Attachment (Hub) to Motor Locking mechanism | While aligning the dots on the iBur™ hub and motor, slide the iBur™ hub onto the motor until it snaps into place. | While aligning the dots on the iBur™ hub and motor, slide the iBur™ hub onto the motor until it snaps into place. | Identical | | | Size / length of attachment | Overall device length when cutting accessory assembled into hub 17.1cm. | Overall device length when cutting accessory assembled into hub 17.1cm. | Identical | | | Nose tube style | Angled | Angled | Identical | | | Cutting accessory head style offering | Round and Match Head | Round and Match Head | Identical | | | Cutting accessories diameter head size | 2.0mm -5.0mm | 2.0mm -5.0mm | Identical | | | Cutting accessory length | One length<br>12.5cm | One length<br>12.5cm | Identical | | Description | | Stryker iBur™ cutting accessories<br>[Subject] | Stryker iBur™ cutting accessories<br>[Predicate K210377] | Explanation of Difference | | | No. of flutes on<br>cutting<br>accessories | Two | Two | Identical | | | Integrated<br>irrigation | Polytube wrapped in a polyurethane<br>heat shrink provides irrigation to the<br>bur head.…