VERTICALE Navigation Instruments

K212007 · Silony Medical GmbH · OLO · Aug 12, 2021 · Neurology

Device Facts

• Record ID: K212007
• Device Name: VERTICALE Navigation Instruments
• Applicant: Silony Medical GmbH
• Product Code: OLO · Neurology
• Decision Date: Aug 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, 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.

Device Story

VERTICALE Navigation Instruments are reusable surgical tools (awls, probes, taps, drivers) used in open spinal surgery. Instruments interface with Medtronic StealthStation navigation system to assist surgeons in precise anatomical localization during pedicle screw placement. Operation involves tracking instrument position relative to patient anatomy (vertebrae) using CT/MR models, fluoroscopy, or digitized landmarks. Output is visual guidance provided via the navigation system display, enabling surgeon to navigate instruments accurately. Benefits include improved precision in screw placement. Used in OR by surgeons.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F2554-18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Results demonstrate sufficient performance for intended use.

Technological Characteristics

Reusable surgical instruments (awls, probes, taps, drivers) made of stainless steel per ASTM F899. Taps range Ø4.5mm to Ø10.2mm. Designed for use with Medtronic StealthStation navigation hardware/software. No internal energy source; passive navigation components.

Indications for Use

Indicated for patients undergoing spinal surgery requiring pedicle screw placement 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

• Medtronic Navigated Instruments (K161210, K143628, K140454, K143375)

Reference Devices

• VERTICALE Posterior Spinal Fixation System (K171421)

Submission Summary (Full Text)

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August 12, 2021

Image /page/0/Picture/1 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Silony Medical GmbH % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K212007

Trade/Device Name: VERTICALE Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 25, 2021 Received: June 28, 2021

Dear Nathan Wright:

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,

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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#### 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 on last page.

510(k) Number (if known) K212007

#### Device Name

VERTICALE® Navigation Instruments

Indications for Use (Describe)

Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, 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.

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, 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 respond to, a collection of information unless it displays a currently valid OMB number. '

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services [phone] EF

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# 5.510(K) SUMMARY

| Submitter's Name: | Silony Medical GmbH |
|----------------------------|------------------------------------------------------------------------------------------|
| Submitter's Address: | Leinfelder Straße 60<br>D-70771 Leinfelden-Echterdingen, Germany |
| Submitter's Telephone: | [phone] |
| Contact Person: | Nathan Wright MS<br>Empirical Testing Corp.<br>719-351-0248<br>[e-mail] |
| | Image: EMPIRICAL TESTING CORP. |
| Date Summary was Prepared: | June 25, 2021 |
| Trade or Proprietary Name: | VERTICALE® Navigation Instruments |
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Classification: | Class II per 21 CFR §882.4620 |
| Product Code: | OLO |
| Classification Panel: | Division of Orthopedic Devices |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Silony Medical VERTICALE® Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.

The VERTICALE® Navigation Instruments include awls, probes, taps, and drivers. The VERTICALE® Navigation Instruments are to be used with the VERTICALE® Posterior Spinal Fixation System.

All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø4.5mm to Ø10.2mm. The VERTICALE® Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

# INDICATIONS FOR USE

Silony Medical Navigation Instruments are intended to be used during the preparation and placement of VERTICALE® pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with stereotactic navigation system Medtronic StealthStation®, 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.

#### TECHNOLOGICAL CHARACTERISTICS

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The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

- Indications for Use
- . Materials of manufacture
- . Principles of Operation

#### Table 5-1 Predicate Devices

| 510k Number | Trade or<br>Proprietary or<br>Model Name | Manufacturer | Predicate<br>Type |
|-----------------------------------------------|---------------------------------------------------|------------------------------------------|-------------------|
| K161210 (PRIMARY)/K143628/<br>K140454/K143375 | Medtronic Navigated<br>Instruments | Medtronic<br>Sofamore Danek<br>USA, Inc. | Primary |
| K171421 | VERTICALE®<br>Posterior Spinal<br>Fixation System | Silony Medical<br>GmbH | Reference |

### Performance Data

The VERTICALE® Navigation Instruments have been tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems".

The results of this non-clinical testing show that performance of the VERTICALE® Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

# CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the VERTICALE® Navigation Instruments is substantially equivalent to the predicate device.