CoreLink Navigation Instruments

K230880 · Corelink, LLC · OLO · May 2, 2023 · Neurology

Device Facts

• Record ID: K230880
• Device Name: CoreLink Navigation Instruments
• Applicant: Corelink, LLC
• Product Code: OLO · Neurology
• Decision Date: May 2, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws 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 Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Story

CoreLink Navigation Instruments are non-sterile, reusable manual surgical instruments; manufactured from stainless steel. Designed for use with Medtronic StealthStation® System S8; instruments interface with navigation system to provide real-time tracking of surgical tools relative to patient anatomy. Used by surgeons in spinal procedures (open or minimally invasive) to assist in precise placement of CoreLink pedicle and sacroiliac screws. System utilizes CT/MR models, fluoroscopy, or digitized landmarks to guide instrument positioning. Output is visual navigation data displayed on the StealthStation® console; assists surgeon in anatomical localization; improves accuracy of screw placement; reduces risk of malpositioning.

Clinical Evidence

Bench testing only. Performance testing per ASTM F2554 was conducted to evaluate positional accuracy. Engineering analysis demonstrated that subject instruments present no new worst-case scenarios for positional accuracy compared to previously cleared instruments (K220973, K212825).

Technological Characteristics

Manual surgical instruments; stainless steel construction. Principle of operation: stereotactic navigation via interface with Medtronic StealthStation® System S8. Reusable; non-sterile. No software or electronic components integral to the instruments themselves; connectivity provided by the host navigation system.

Indications for Use

Indicated for use in spinal surgery to assist surgeons in locating anatomical structures for the preparation and placement of CoreLink screws in open or minimally invasive procedures. Compatible with Medtronic StealthStation® System S8 for conditions requiring stereotactic surgery.

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

• CoreLink Navigation Instruments (K220973)
• Medtronic Navigated Reusable Instruments (K170679)
• Nextgen Pedicle Screw System (K221776)

Submission Summary (Full Text)

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May 2, 2023

CoreLink, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K230880

Trade/Device Name: CoreLink Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 30, 2023 Received: March 30, 2023

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

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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 (QS) 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,

Shumaya Ali-S

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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# Indications for Use

Submission Number (if known)

K230880

Device Name

CoreLink Navigation Instruments

#### Indications for Use (Describe)

CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws 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 Medtronic StealthStation® System S8 (V1.2.0), 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 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 K230880

| Submitter's Name: | CoreLink, LLC |
|--------------------------------|-----------------------------------------------------------------------------------------|
| Submitter's Address: | 2072 Fenton Logistics Park<br>St. Louis, Missouri 63026 |
| Submitter's Telephone: | 888-349-7808 |
| Contact Person: | Nathan Wright MS<br>Empirical Technologies<br>719-351-0248<br>[e-mail] |
| Date Summary was Prepared: | May 1, 2023 |
| Trade or Proprietary Name: | CoreLink Navigation Instruments |
| Common Name: | Orthopedic Stereotaxic Instruments |
| Device Classification Name: | Stereotaxic Instrument |
| Classification & Regulation #: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Orthopedic - Stereotaxic, Trauma, and Restorative Devices (DHT6C) |

#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

CoreLink Navigation Instruments are non-sterile, re-usable manual surgical instruments made from stainless steel for use with CoreLink pedicle screw and sacroiliac screw systems. These instruments are designed to interface with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The purpose of this submission is to add instruments to the previously cleared CoreLink Navigation Instruments set to offer navigation compatibility with additional CoreLink pedicle screws.

# INDICATIONS FOR USE

CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws 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 Medtronic StealthStation® System S8 (V1.2.0), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

#### TECHNOLOGICAL CHARACTERISTICS

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

#### Predicate Devices

| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|-------------|------------------------------------|---------------|----------------|
| K220973 | CoreLink Navigation Instruments | CoreLink, LLC | Primary |

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| K170679 | Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek | Additional |
|---------|------------------------------------------|-------------------------|------------|
| K221776 | Nextgen Pedicle Screw System | CoreLink, LLC | Additional |

## Performance Data

Performance testing per ASTM F2554 has been conducted to evaluate positional accuracy of the CoreLink Navigation Instruments as submitted under previous submissions of the CoreLink Navigation Instruments (K220973, K212825). An engineering analysis has been performed to show that the subject instruments present no new worst case for positional accuracy and that the previous testing is representative of the subject instruments.

### CONCLUSION

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