K2M Navigation Instruments

K171321 · K2m · OLO · Aug 30, 2017 · Neurology

Device Facts

• Record ID: K171321
• Device Name: K2M Navigation Instruments
• Applicant: K2m
• Product Code: OLO · Neurology
• Decision Date: Aug 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. The K2M Navigation Instruments are designed for use with the Medtronic 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.

Device Story

K2M Navigation Instruments are manual surgical tools designed to interface with the Medtronic StealthStation® System. These instruments assist surgeons in spinal procedures by providing navigation for the placement of K2M spinal screws (DENALI, MESA, EVEREST). The instruments act as physical trackers or guides that the StealthStation system recognizes to correlate the position of the surgical tool with pre-operative or intra-operative imaging (CT, MR, or fluoroscopy). By tracking the instrument relative to rigid anatomical structures (vertebrae), the system provides real-time visual feedback to the surgeon on a display. This allows for precise anatomical localization during screw insertion, potentially improving surgical accuracy and reducing the need for repeated imaging. The devices are used in clinical settings (OR) by surgeons.

Clinical Evidence

Bench testing only. Performance evaluation included rigidity, registration, and accuracy testing to ensure functionality and compatibility with the Medtronic StealthStation system. No clinical data was provided.

Technological Characteristics

Manual surgical instruments designed for compatibility with the Medtronic StealthStation navigation system. Materials and design features are consistent with previously cleared K2M spinal system components. The system relies on external optical or electromagnetic tracking (via the StealthStation) to determine instrument position relative to patient anatomy. No internal energy source or software algorithm; the instruments are passive mechanical components.

Indications for Use

Indicated for use in spinal surgery to assist surgeons in precisely locating anatomical structures during the preparation and placement of K2M screws (DENALI, MESA, EVEREST). MESA screw navigation is restricted to open procedures; others may be used in open or minimally invasive procedures. Designed for use with the Medtronic StealthStation® System for conditions where stereotactic surgery is appropriate.

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 (K143375)
• Medtronic Navigated Instruments (K143628)
• K2M Range/Mesa/Denali Spinal System (K070229)
• K2M Range/Mesa/Denali Spinal System (K153031)
• K2M Everest Spinal System (K103440)
• K2M Everest Spinal System (K161369)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 30, 2017

K2M Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175

Re: K171321

Trade/Device Name: K2M Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 31, 2017 Received: August 1, 2017

Dear Nancy Giezen:

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. 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 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K171321

Device Name K2M Navigation Instruments

#### Indications for Use (Describe)

K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALL MESA. EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. The K2M Navigation Instruments are designed for use with the Medronic 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

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 801 Subpart C)

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## 510(k) SUMMARY K2M Navigation Instruments

#### Submitter

K2M 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: [phone] Date Prepared: 7/26/2017

## Classification

Trade Name: K2M Navigation Instruments Common Name: Navigation Instrument Regulatory Class: Class II

Classification Name(s): Stereotaxic instrument (21 CFR 882.4560, Product Code OLO)

### Predicate Device(s)

Primary Predicate: Medtronic Navigated Instruments (K143375) Additional Predicates: Medtronic Medtronic Navigated Instruments (K143628, K143375) K2M Range/Mesa/Denali Spinal System (K070229, K153031) K2M Everest Spinal System (K103440, K161369)

## Device Description

K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI and EVEREST Spinal Systems.

Function: These instruments are designed to interface with the Medtronic StealthStation® System when used for navigation during spinal surgery.

### Intended Use

K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. The K2M Navigation Instruments are designed for use with the Medtronic 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.

Technological Comparison to Predicate(s)

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K2M Navigation Instruments were compared to predicate devices and the design features, materials and indications were the same or similar to the previously cleared devices.

## Non-clinical Performance Evaluation

Rigidity, registration, and accuracy testing was performed to ensure functionality and compatibility with the Medtronic StealthStation. The results of testing determined that the K2M Navigation Instruments are equivalent to predicate devices.

## Conclusion

There are no significant differences between the K2M Navigation Instruments and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.