Kalitec Navigated Instrument System

K232572 · Kalitec Direct, LLC Doing Business AS Kalitec Medical · OLO · Dec 13, 2023 · Neurology

Device Facts

• Record ID: K232572
• Device Name: Kalitec Navigated Instrument System
• Applicant: Kalitec Direct, LLC Doing Business AS Kalitec Medical
• Product Code: OLO · Neurology
• Decision Date: Dec 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 for the anatomy. Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.

Device Story

System consists of nonsterile, reusable manual instruments (probes, taps, drivers) used in spinal surgery; designed for integration with Medtronic StealthStation S8 navigation system, NavLock trackers, and SureTrak clamps/arrays. Surgeon uses instruments to locate anatomical structures for pedicle screw placement; navigation system provides real-time tracking relative to pre-operative CT/MR images or intra-operative fluoroscopy. Output is visual guidance on navigation display; assists surgeon in precise instrument positioning. Benefits include improved accuracy in screw placement during open or minimally invasive procedures. Used in OR by surgeons.

Clinical Evidence

Bench testing only. Dimensional accuracy validation performed per ASTM F2554 comparing subject device performance against Medtronic StealthStation system and predicate device. No clinical data presented.

Technological Characteristics

Reusable manual instruments (probes, taps, drivers). Compatible with Medtronic StealthStation S8 navigation system, NavLock trackers, and SureTrak clamps/arrays. Dimensional accuracy validated per ASTM F2554. Nonsterile. No internal software; relies on external navigation system for tracking.

Indications for Use

Indicated for use during spinal surgery for screw preparation and placement in open or minimally invasive procedures. Intended for patients requiring stereotactic surgery where rigid anatomical structures (e.g., vertebrae) can be referenced via CT, MR, fluoroscopy, or digitized landmarks. Limited to use with Kalitec pedicle screw systems.

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 CD Horizon Solera Screwdrivers and Taps (K124004, K140454)
• CosmoLock Pedicle Screw System (K140678, K172808)

Submission Summary (Full Text)

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December 13, 2023

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Kalitec Direct, LLC doing business as Kalitec Medical % J.D. Webb President The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401

Re: K232572

Trade/Device Name: Kalitec Navigated Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 9, 2023 Received: November 13, 2023

Dear J.D. Webb:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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### K232572 - J.D. Webb

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-S

Shumaya Ali, MPH

Shumaya Ali, M 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

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## Indications for Use

Submission Number (if known)

K232572

Device Name

Kalitec Navigated Instrument System

Indications for Use (Describe)

The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalitec Navigated Instruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 for the anatomy. Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 510(k) #: K232572 | 510(k) Summary | | Prepared on: 2023-11-09 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--|-------------------------|
| Contact Details | | | 21 CFR 807.92(a)(1) |
| Applicant Name | Kalitec Direct, LLC doing business as Kalitec Medical | | |
| Applicant Address | 618 E. South Street Suite 500 Orlando FL 32801 United States | | |
| Applicant Contact Telephone | 407-545-2063 | | |
| Applicant Contact | Mr. Winn Scott | | |
| Applicant Contact Email | [e-mail] | | |
| Correspondent Name | The OrthoMedix Group, Inc., | | |
| Correspondent Address | 4313 W. 3800 S. West Haven UT 84401 United States | | |
| Correspondent Contact Telephone | 512-590-5810 | | |
| Correspondent Contact | Mr. J.D. Webb | | |
| Correspondent Contact Email | [e-mail] | | |
| Device Name<br>21 CFR 807.92(a)(2) | | | |
| Device Trade Name | Kalitec Navigated Instrument System | | |
| Common Name | Stereotaxic instrument | | |
| Classification Name | Orthopedic Stereotaxic Instrument | | |
| Regulation Number | 882.4560 | | |
| Product Code | OLO | | |
| Legally Marketed Predicate Devices<br>21 CFR 807.92(a)(3) | | | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | | Product Code |
| K124004/K140454/ | Medtronic Navigated CD Horizon Solera Screwdrivers and Taps | | OLO |
| K140678/K172808 | CosmoLock Pedicle Screw System | | MNI |
| Device Description Summary | | | 21 CFR 807.92(a)(4) |
| The Kalitec Navigated Instrument System is comprised of nonsterile, reusable instruments, including probes, taps, and drivers that can<br>be operated manually. These instruments are designed to function with the Medtronic StealthStation® S8(v2.0.1-7) System, in<br>combination with the Medtronic NavLock™ tracker and Medtronic SureTrak®Il clamps and arrays to assist surgeons in precisely locating<br>anatomical structures in open or minimally invasive procedures for preparation and placement of Kalitec polyaxial screws. | | | |

# Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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The Kalitec Navigated Instrument System is indicated for use during the preparation and placement of screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Kalited Navigated lnstruments System reusable instruments are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 for the anatomy.

Use of the Kalitec Navigated Instruments is limited to use only with Kalitec pedicle screw systems.

## Indications for Use Comparison

The Kalitec Navigated Instrument System has the same indications for use as the predicate Medtronic device.

## Technological Comparison

Indications for Use: no difference Materials: no difference Software & Hardware Compatibility: no difference Navigation Instrument Critical Length Dimension: no difference Operating Principle: no difference Sterility: no difference

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The Kaltec Navigated Instrument System dimensional accuracy (per ASTM F2554) validations were performed in side-by-side testing of the Medtronic® StealthStation® system and predicate device. The test results demonstrate that the Kalitec Navigated Instrument System performance is substantially equivalent to the predicate.

Not Applicable

Kallitec Direct, LLC considers the Kalitec Navigated Instrument System to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.

21 CFR 807.92(a)(5)

## 21 CFR 807.92(a)(6)