Navigation Module of the Momentum System

K200845 · Ulrich Medical USA · OLO · Sep 10, 2020 · Neurology

Device Facts

• Record ID: K200845
• Device Name: Navigation Module of the Momentum System
• Applicant: Ulrich Medical USA
• Product Code: OLO · Neurology
• Decision Date: Sep 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Navigation Module of the Momentum System is intended to be used during the preparation and placement of Momentum Posterior Spinal Fixation System screws during spinal surgery, to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigation Module of the Momentum System is designed for use with the Medtronic SteathStation 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 vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks for the anatomy.

Device Story

Navigation Module of the Momentum System consists of non-sterile, reusable manual surgical instruments (taps and screwdrivers); used in conjunction with Medtronic StealthStation System for spinal surgery. Instruments interface with navigation system to track position relative to patient anatomy (vertebrae) using CT/MRI models, fluoroscopy, or digitized landmarks. Surgeon uses instruments to prepare bone and place pedicle screws in open or minimally invasive procedures. Navigation provides real-time visual feedback on instrument position, assisting surgeon in precise anatomical targeting. Benefits include improved accuracy in screw placement and potential reduction in surgical complications. System is operated by surgeons in clinical/OR settings.

Clinical Evidence

Bench testing only. Performance validated through side-by-side testing of the Navigation Module and predicate devices, assessing navigation accuracy, registration, rigidity, and simulated surgery performance.

Technological Characteristics

Manual surgical instruments (taps, screwdrivers) manufactured from stainless steel per ASTM F899. Designed for integration with Medtronic StealthStation navigation system. Reusable, non-sterile. No active electronic components; passive navigation markers.

Indications for Use

Indicated for patients undergoing spinal surgery requiring preparation and placement of Momentum Posterior Spinal Fixation System screws, where stereotactic navigation is appropriate for locating anatomical structures.

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

• Navigated CD Horizon® Solera® Screwdrivers and Taps (K140454)
• Navigated CD Horizon® Solera™ Screwdrivers, CD Horizon® Solera™ Taps and CD Horizon® Legacy™ Taps (K124004)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 10, 2020

Ulrich Medical USA Hans Stover President & CEO 18221 Edison Avenue Chesterfield, Missouri 63005

Re: K200845

Trade/Device Name: Navigation Module of the Momentum System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 30, 2020 Received: August 13, 2020

Dear Hans Stover:

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.

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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 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 medical devices and radiation-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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200845

Device Name Navigation Module of the Momentum System

## Indications for Use (Describe)

The Navigation Module of the Momentum System is intended to be used during the preparation and placement of Momentum Posterior Spinal Fixation System screws during spinal surgery, to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigation Module of the Momentum System is designed for use with the Medtronic SteathStation 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 vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks for the anatomy.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" width="15"></rect> <line stroke="black" stroke-width="2" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" stroke-width="2" x1="13" x2="2" y1="2" y2="13"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" width="15"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## K200845 510(k) Summary

Image /page/3/Picture/1 description: The image shows the logo for Ulrich medical USA. The logo consists of the word "Ulrich" in a bold, sans-serif font, with the "U" in white against a black square. Below the word "Ulrich" is the phrase "medical USA" in a smaller, sans-serif font.

| Date: | 30 March 2020 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | ulrich medical USA, Inc. |
| | 18221 Edison Avenue |
| | Chesterfield, MO 63005 |
| | [phone] Office |
| | [phone] Fax |
| Sponsor Contact: | Hans Stover, President & CEO |
| Proposed Trade<br>Name: | Navigation Module of the Momentum System |
| Common Name: | Orthopaedic navigation system |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 882.4560 |
| Regulation Name: | Stereotaxic Instrument |
| Product Code: | OLO |
| Device Description: | The Navigation Module of the Momentum System contains non-sterile,<br>reusable manual instruments including taps and screwdrivers. The<br>instruments are designed for use with the Medtronic StealthStation System<br>for implantation of the Momentum Posterior Spinal Fixation System<br>components. |
| Indications for Use: | The Navigation Module of the Momentum System is intended to be used<br>during the preparation and placement of Momentum Posterior Spinal Fixation<br>System screws during spinal surgery, to assist the surgeon in precisely<br>locating anatomical structures in either open or minimally invasive<br>procedures. The Navigation Module of the Momentum System is designed<br>for use with the Medtronic SteathStation System, which is indicated for any<br>medical condition in which the use of stereotactic surgery may be<br>appropriate, and where reference to a rigid anatomical structure, such as a<br>vertebra, can be identified relative to a CT or MRI based model, fluoroscopy<br>images, or digitized landmarks for the anatomy. |
| Materials: | The Navigation Module instruments are manufactured from stainless steels<br>per ASTM F899. |
| Primary Predicate: | Navigated CD Horizon® Solera® Screwdrivers and Taps (Medtronic Sofamor<br>Danek, USA Inc. – K140454) |
| Additional Predicates: | Navigated CD Horizon® Solera™ Screwdrivers, CD Horizon® Solera™ Taps<br>and CD Horizon® Legacy™ Taps (Medtronic Navigation, Inc. – K124004) |
| Performance Data: | Navigation accuracy, registration, rigidity and simulated surgery validations<br>were performed in side-by-side testing of the Navigation Module of the<br>Momentum System and predicate devices. The test results demonstrate that<br>the Navigation Module of the Momentum System performance is<br>substantially equivalent to the predicate devices. |
| Technological<br>Characteristics: | The Navigation Module of the Momentum System possesses similar<br>technological characteristics as one or more of the predicate devices. The<br>fundamental scientific technology of the Navigation Module of the Momentum<br>System is the same as previously cleared devices. |

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The Navigation Module of the Momentum System possesses the same Conclusion: intended use and similar technological characteristics as the predicate devices. The Navigation Module of the Momentum System is substantially equivalent for its intended use.