CD Horizon™ Spinal System

K231184 · Medtronic Sofamor Danek USA, Inc. · OLO · May 26, 2023 · Neurology

Device Facts

• Record ID: K231184
• Device Name: CD Horizon™ Spinal System
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: OLO · Neurology
• Decision Date: May 26, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 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 instrument.

Device Story

Surgical instruments for spinal implant preparation/placement; used in open or minimally invasive procedures. Instruments include manual navigated/non-navigated tools, drills, and cannulas. Proximal shafts feature bushings for NavLock™ tracker attachment for optical navigation with MAZOR X Stealth™ Edition. Some instruments compatible with IPC™ POWEREASE™ or AO-style motors. Surgeon operates instruments manually or via MAZOR X arm guide. Output is physical preparation of bone/implant site; navigation system provides visual feedback on instrument position relative to patient anatomy. Benefits include precise anatomical localization and trajectory guidance during spinal instrumentation.

Clinical Evidence

Bench testing only. Validation included design validation, anatomical simulated use, navigation simulated use, and navigation accuracy analysis to confirm functionality and compatibility with the MAZOR X Stealth™ Edition system.

Technological Characteristics

Reusable/single-use orthopedic surgical instruments; materials meet national/international standards. Features proximal bushings for optical tracker attachment and geometry compatible with MAZOR X arm guides. Manual operation; some compatible with power drivers. Non-sterile delivery.

Indications for Use

Indicated for patients undergoing spinal surgery where stereotactic navigation is appropriate and anatomical structures (e.g., vertebrae) can be referenced via CT/MR models, fluoroscopy, or digitized landmarks.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• CD Horizon™ Spinal System Instruments for use with Mazor X Stealth™ Edition (K182121)
• CD Horizon™ Spinal System (K211596)

Reference Devices

• NavLock™ trackers (K171267, K182104, K201327)
• POWEREASE™ Driver (K111520)

Submission Summary (Full Text)

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May 26, 2023

Medtronic Sofamor Danek, USA Inc. Justin O'connor Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K231184

Trade/Device Name: CD Horizon™ Spinal System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 25, 2023 Received: April 26, 2023

Dear Justin O'connor:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali-S

Shumaya Ali, M.P.H. 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

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### Indications for Use

510(k) Number (if known)

#### Device Name

Medtronic Surgical 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 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 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 instrument.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:10pt"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# K231184

# 510(k) Summary

# MEDTRONIC CD HORIZON™ Spinal System

# April 25, 2023

| I. Submitter | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone] |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Justin O'Connor<br>Sr. Regulatory Affairs Specialist<br>Email: [e-mail] |
| Date Prepared | April 25, 2023 |
| II. Name of Device | CD Horizon™ Spinal System |
| Common Name | Orthopedic Stereotaxic Instruments, Navigated Instruments |
| Classification Name | Stereotaxic Instruments |
| Classification | Instruments/Accessories: Class II |
| Product Codes | OLO (882.4560) |
| III. Predicate Devices | Primary Predicate:<br>CD Horizon™ Spinal System Instruments for use with Mazor X<br>Stealth™ Edition (K182121, S.E. 11/02/2018)<br>Additional Predicate:<br>CD Horizon™ Spinal System (K211596, S.E. 06/23/2021)<br>The predicates have not been subject to a design related recall. |
| IV. Description | Medtronic Surgical Instruments for use with Mazor X<br>Stealth™ Edition |
| | The CD HORIZON™ Spinal System surgical instruments are non-<br>sterile or sterile, single, or re-usable instruments that may be used<br>during the preparation and placement of various Medtronic spinal<br>implants during spinal surgery. The subject instruments are made<br>of a variety of materials commonly used in orthopedic and<br>neurological procedures which meet available national or<br>international standards specifications. Single-use Medtronic<br>Surgical instruments should never be reused under any<br>circumstances. |
| | The CD Horizon™ instruments are intended to be used when<br>preparing and placing Medtronic screws during spinal surgery. To<br>enable optical navigation compatibility of the surgical instruments<br>with the MAZOR X Stealth™ Edition System, the proximal ends<br>of the instrument shafts have been designed with a bushing that<br>provides a connection site where the NavLock™ trackers<br>(K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E.<br>06/18/2020) can be attached. To enable trajectory guidance<br>compatibility of the surgical instruments with the Mazor X<br>Stealth™ Edition, the instrument dimensions have been designed to<br>work with the Mazor X arm guides. The subject RG FAS Drivers<br>may also be operated under power when attached to the<br>POWEREASE™ Driver (K111520, S.E. 10/26/2011). |
| | The subject instruments are reusable and will be provided non-<br>sterile. |
| V. Indications for Use | Medtronic Surgical Instruments for use with Mazor X<br>Stealth™ Edition |
| | Medtronic Surgical Instruments are intended to be used during<br>preparation and placement of Medtronic implants during spinal<br>surgery to assist in precisely locating anatomical structures in either<br>open, or minimally invasive, procedures. Medtronic Surgical<br>Instruments are specifically designed for use with the Mazor X<br>Stealth™ Edition, which is indicated for medical conditions in<br>which the use of stereotactic surgery may be appropriate, and<br>where reference to a rigid anatomical structure, such as a<br>vertebra, can be identified relative to a CT or MR-based model,<br>fluoroscopy images, or digitized landmarks of the anatomy. |
| | Medtronic Surgical Instruments can be navigated or non-navigated<br>manual instruments that may or may not be guided through the<br>Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills<br>shall only be used through the Mazor X Stealth™ Edition arm<br>guides, Medtronic cannulas, and Medtronic drill guides. Some of<br>the Medtronic Surgical Instruments are also compatible with the<br>IPCT™ Powerease™ System or AO* style quick connect drilling<br>motors. An instrument may incorporate a measuring function which<br>has uses as described on the label and the instrument. |
| VI. Comparison of<br>Technological<br>Characteristics with<br>the Predicate Devices | The subject instruments have the same intended use, indications,<br>material, fundamental technology, and sterilization method as the<br>instruments in the following CD Horizon™ Spinal System<br>predicates: |
| | CD Horizon™ Spinal System Instruments for use with<br>Mazor X Stealth™ Edition (K182121, S.E. 11/02/2018) CD Horizon™ Spinal System (K211596, S.E. 06/23/2021) |
| VII. Performance Data | The following verification/validation activities were completed to<br>ensure functionality and compatibility with the subject instruments: |
| | Design Validation and Anatomical Simulated Use –<br>Confirmed instrument functionality under expected use<br>conditions Navigation Simulated Use – Confirmed navigation system<br>functionality under expected use conditions Navigation Accuracy Analysis – Confirmed navigated<br>instrument accuracy |
| VIII. Conclusion | The CD HORIZON™ ModuLeX™ Instruments for use with the<br>Mazor X Stealth™ Edition have shown to be substantially<br>equivalent to the predicates listed above. |

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