K2M Navigation Instruments

K171556 · K2m · OLO · Jan 16, 2018 · Neurology

Device Facts

• Record ID: K171556
• Device Name: K2M Navigation Instruments
• Applicant: K2m
• Product Code: OLO · Neurology
• Decision Date: Jan 16, 2018
• 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 pedicle screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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 Brainlab Navigation System. Used by surgeons during spinal procedures to assist in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST). Instruments facilitate precise location of anatomical structures in open or minimally invasive surgeries. They function by providing physical guidance that integrates with the navigation system's tracking of rigid anatomical structures relative to CT, MR, or fluoroscopic images. The output is the physical placement of implants; the benefit is enhanced surgical accuracy in spinal instrumentation.

Clinical Evidence

Bench testing only. Dimensional comparisons and simulated use testing were performed to verify functionality and compatibility with the Brainlab Navigation System. No clinical data was required or provided.

Technological Characteristics

Manual surgical instruments designed for compatibility with the Brainlab Navigation System. Materials and design features are similar to previously cleared predicate devices. No electronic components, software, or energy sources are integral to the instruments themselves; they serve as mechanical interfaces for the navigation system.

Indications for Use

Indicated for use in spinal surgery to assist surgeons in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST) by precisely locating anatomical structures in open or minimally invasive procedures. Used in conjunction with the Brainlab Navigation system for conditions where stereotactic surgery is appropriate and rigid anatomical structures (skull, long bone, vertebra) can be referenced to imaging 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

• Brainlab Spine and Trauma (K083310)
• DePuy VIPER® and EXPEDIUM® navigated instruments (K120867)
• Range/Mesa/Denali Spinal System (K171832)
• Everest Spinal System (K161369)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for 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.

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

Re: K171556

Trade/Device Name: K2M Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 14, 2017 Received: December 18, 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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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K171556

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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

Enclosure

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# 510(k) SUMMARY K2M Navigation Instruments

#### Submitter

K2M, Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: [phone] Date Prepared: 12/14/2017

#### 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: Brainlab Spine and Trauma (K083310) Additional Predicates: DePuy VIPER® and EXPEDIUM® navigated instruments (K120867) Range/Mesa/Denali Spinal System (K171832) Everest Spinal System (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 Brainlab Navigation 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 pedicle screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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.

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## Technological Comparison to Predicate(s)

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

Dimensional comparisons and simulated use testing was performed to ensure functionality and compatibility with the Brainlab Navigation System. The results of these evaluations 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.

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# Indications for Use

510(k) Number (if known) K171556

Device Name

K2M Navigation Instruments

#### Indications for Use (Describe)

K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:1.2em;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:1.2em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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