CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Medtronic Sofamor Danek USA, Inc. Erikka Edwardsen Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132 November 2, 2018 Re: K182121 Trade/Device Name: CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 31, 2018 Received: November 1, 2018 Dear Erikka Edwardsen: This letter corrects our substantially equivalent letter of November 2, 2018 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 {1}------------------------------------------------ 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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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, Jesse Muir -S Digitally signed by Jesse Muir -S Date: 2018.11.02 16:01:49 -04'00 For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use # 510(k) Number (if known) K182121 ### Device Name CD HORIZON Spinal System Instruments for use with MAZOR X Stealth™ Edition ### Indications for Use (Describe) Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the instrument. DO NOT IMPLANT THE INSTRUMENTS **Type of Use (Select one or both, as applicable)** X 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, fo: > 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}------------------------------------------------ ## K182121 ## 510(k) SUMMARY ### October 31, 2018 - I. Medtronic Sofamor Danek, USA Inc. Company: 1800 Pyramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133 - Contact: Erikka Edwardsen Senior Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: rikka.r.edwardsen(@medtronic.com Shweta Sharma Principal Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: shweta.s.sharma@medtronic.com #### Proprietary Trade Name: CD HORIZON™ Spinal System Instruments for use II. with MAZOR X Stealth Edition Common Name: Stereotaxic Instrument, Navigated Instruments Classification Name: Stereotaxic Instrument (21 CFR 882.4560) Classification: Class II Product Code: OLO #### III. Predicate Devices: Primary Predicate: Navigated CD HORIZON™ SOLERA™ Spinal System (K140454, S.E. 05/22/2014) Reference Predicates: CD HORIZON™ BALLAST™ Spinal System (K153442, S.E. 02/18/2016) MAZOR X (K163221, S.E. 04/04/2017) Navigated CD HORIZON™ SOLERATM Spinal System (K124004, S.E 03/22/2013) IPCTM POWEREASE™ System (K111520, S.E. 10/26/2011) This predicate devices have not been subject to a design-related recall. {4}------------------------------------------------ #### IV. Device Description: The CD HORIZON™ Spinal System surgical instruments are non-sterile, single or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances. The CD HORIZON™ instruments are specifically designed for use in spinal procedures with MAZOR X Stealth™ Edition. The instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Some instruments (e.g. drills, drivers, taps etc.) are also compatible with Medtronic's IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver, these CD HORIZON™ instruments may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, cannulas, and drill guides. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allow MAZOR X Stealth™ Edition to track the Medtronic instruments in the surgical field. #### Indications for Use: V. Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used {5}------------------------------------------------ through the MAZOR X arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. DO NOT IMPLANT THE INSTRUMENTS ### Comparison of the Technological Characteristics with the Predicate Device: VI. The CD HORIZON™ instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the MAZOR X Stealth™ Edition. Like the predicate devices, the subject instruments work through an arm guide for trajectory guidance and attach to NavLock™ Trackers to allow for optical navigation. The subject devices have similar designs, principle of operation, fundamental scientific technology, material, intended use, as the predicate devices and incorporate the same design features to enable navigation, arm guide compatibility and use with the IPC™ POWEREASE™ System, when desired. The only difference between the subject and predicate devices is, the predicate devices are navigated on the Stealth ™ Station and the predicate devices are navigated via the MAZOR XTM Stealth Edition. #### Performance Data: VII. Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed: {6}------------------------------------------------ | Test | Description | |-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | Navigation<br>Accuracy Analysis | Confirmed navigated instrument accuracy | | Anatomical<br>Simulated Use | Confirmed instrument functionality under expected use conditions | | Navigation<br>Simulated Use | Confirmed navigation system functionality under expected use<br>conditions | | CAD Model<br>Evaluation | Verified that the CAD models are accurately reflected in the<br>application software | | Navigation<br>Software Module<br>Instrument<br>Functional Testing | Verified that the instrument attributes are correctly implemented in<br>the navigation software module. | ### Conclusions VIII. The CD HORIZON™ Instruments for use with the MAZOR X Stealth™ Edition have shown through comparison and testing to be substantially equivalent to the identified predicate devices.