CD Horizon Spinal System Instruments

K203291 · Medtronic Sofamor Danek USA, Inc. · OLO · Dec 8, 2020 · Neurology

Device Facts

• Record ID: K203291
• Device Name: CD Horizon Spinal System Instruments
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: OLO · Neurology
• Decision Date: Dec 8, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, 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 Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System. Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition 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 Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Mectronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

Device Story

CD Horizon Spinal System Instruments are non-sterile, reusable manual surgical instruments used for screw/implant placement during spinal surgery. Instruments integrate with Medtronic StealthStation and MAZOR X Stealth Edition systems via NavLock trackers and sterile spheres; these allow computer-assisted tracking of instrument position relative to patient anatomy. Used by surgeons in OR settings for open or minimally invasive procedures. Instruments may be used with IPC POWEREASE or manual handles. Navigation provides real-time visual feedback on surgical displays, assisting precise anatomical localization. Benefits include improved surgical accuracy and guidance during complex spinal instrumentation.

Clinical Evidence

Bench testing only. Testing included navigation accuracy verification, CAD model verification, tools package functional verification, and anatomical simulated use testing to validate design outputs against user needs.

Technological Characteristics

Reusable manual surgical instruments; materials meet national/international standards for orthopedic/neurological use. Features include NavLock tracker compatibility for optical/electromagnetic tracking. Compatible with IPC POWEREASE and AO-style drilling motors. Non-sterile delivery.

Indications for Use

Indicated for patients undergoing spinal surgery requiring preparation and placement of Medtronic screws or implants; applicable for open or minimally invasive procedures where stereotactic navigation is appropriate using CT, MR, fluoroscopy, or digitized anatomical 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™ SOLERA Instruments (K140454)
• CD Horizon™ Spinal System Instruments (K182121)

Reference Devices

• IPC POWEREASE™ System (K111520)

Submission Summary (Full Text)

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December 8, 2020

Image /page/0/Picture/1 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.

Medtronic Sofamor Danek USA, INC. Erikka Edwardsen Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

#### Re: K203291

Trade/Device Name: CD Horizon Spinal System Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 6, 2020 Received: November 9, 2020

#### Dear Erikka Edwardsen:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (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 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,

For: 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)

#### K203291

Device Name CD Horizon™ Spinal System Instruments

#### Indications for Use (Describe)

Indications for Use Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, 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 Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System.

Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition

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 Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Mectronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

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)

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## 510(k) Summary

# November 6, 2020

| I. Submitter: | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone] |
|---------------|-----------------------------------------------------------------------------------------------------------------|
|---------------|-----------------------------------------------------------------------------------------------------------------|

| Contact: | Erikka Edwardsen<br>Sr Regulatory Affairs Specialist<br>Telephone Number: [phone]<br>Email: [e-mail] |
|----------|------------------------------------------------------------------------------------------------------------------------------------|
|----------|------------------------------------------------------------------------------------------------------------------------------------|

## II. Device:

| Proprietary Trade Name: | CD Horizon™ Spinal System |
|-------------------------|-----------------------------------------------|
| Common Name: | Stereotaxic Instrument, Navigated Instruments |
| Classification Name: | Stereotaxic Instrument |
| Regulation Numbers: | Class II (21 CFR 882.4560) |
| Classification: | Class II |
| Product Code: | OLO |

#### III. Predicates:

Predicate:

- Primary Predicate: CD Horizon™ SOLERA Instruments (K140454, S.E. . 05/22/2014)
- Additional Predicate: CD Horizon™ Spinal System Instruments (K182121, S.E. . 11/02/2018)

The predicate devices have not been subject to a design-related recall.

## IV. Product Description:

The subject CD Horizon™ Spinal System drivers are non-sterile instruments that may be used during placement of various Medtronic screws during spinal surgery. The Medtronic

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instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. The subject CD Horizon™ Spinal System drivers are compatible with POWEREASE, Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system to track the instruments in the surgical field.

## V. Indications for Use

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, 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 Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System.

### Medtronic Surgical Instruments for use with MAZOR X StealthTM Edition

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 Stealth™ Edition Arm Guide. Medtronic surgical drills

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shall only be used through the MAZOR X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

## VI. Comparison of Technological Characteristics:

The subject CD Horizon™ instruments are intended to be used during the placement of Medtronic screws during spinal surgery. 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 and compatibility and use with IPC™ POWEREASE™ System when desired.

The only change to the subject CD Horizon™ Spinal System drivers (K182121, S.E. 11/02/2018) is the expanded indications. Expanding the indications will provide surgeons additional driver options during procedures currently enabled on the StealthStation™ system. The subject drivers will have the same indications for use as the CD Horizon Solera™ drivers (K140454, S.E. 05/22/2014). The devices continue to be compatible with the Mazor X Stealth Edition, NavLock Trackers, the IPC POWEREASE System (K111520, S.E. 10/26/2011) quick connect manual handles and CD Horizon Spinal System bone screws

#### VII. Discussion of the Performance Testing:

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The test results show that the subject device and the predicate device are equivalent.

| Test | Description |
|--------------------------------|------------------------------------------------------------------------------------------|
| Navigation Accuracy<br>Testing | Confirmed navigated instrument accuracy |
| CAD Model Verification | Confirm the driver's CAD models are accurately reflected<br>in the application software. |

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| Tools Package<br>Functional Verification<br>Testing | Provides confirmation that the Spine tools package has met<br>the required interface needs of the spine application<br>software. |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Navigated Simulated Use | Validate that the design outputs meet the requirements<br>associated with customer needs. |
| Anatomical Simulated<br>Use Testing | User needs are satisfied by performing simulated testing per<br>the instructions outlined in the surgical techniques |

## VIII. Conclusion:

Based on the supporting information provided in this pre-market notification, the subject CD Horizon™ Spinal System Drivers are substantially equivalent to CD HORIZON SOLERA Instruments (K140454, S.E. 05/22/2014)