Ion-C Navigation Instruments
Device Facts
| Record ID | K260329 |
|---|---|
| Device Name | Ion-C Navigation Instruments |
| Applicant | SurGenTec, LLC |
| Product Code | OLO · Neurology |
| Decision Date | May 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ION-C Navigation Instruments are intended to be used with the ION-C System Facet Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures, specifically the cervical facet joint, in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medtronic StealthStation System S8, 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 the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy must be used to confirm final implant placement.
Device Story
Ion-C Navigation Instruments consist of locators, drill, and inserter; used with Medtronic NavLock Array and StealthStation S8 navigation system. Instruments assist surgeons in locating cervical facet joints during spinal surgery; open or minimally invasive procedures. Device provides physical guidance for implanting Ion-C System Facet Implants. Surgeon uses navigation system to reference anatomical structures relative to pre-operative or intra-operative imaging (CT/MRI/fluoroscopy). Output is visual guidance on navigation display; assists in precise instrument positioning. Fluoroscopy required for final implant confirmation. Benefits include improved surgical accuracy and anatomical targeting.
Clinical Evidence
Bench testing only. Includes sterilization validation (ISO 17664, ISO 11137), biocompatibility assessments (ISO 10993), and engineering analyses of critical geometry. No clinical data presented.
Technological Characteristics
Instruments include locators, drill, and inserter. Materials and critical geometry match predicates. Compatible with Medtronic StealthStation S8 and NavLock Array. Sterilization per ISO 17664 and ISO 11137. Biocompatibility per ISO 10993.
Indications for Use
Indicated for patients undergoing spinal surgery requiring precise location of cervical facet joints in open or minimally invasive procedures; used with Medtronic StealthStation System S8 for stereotactic surgery where rigid anatomical structures (pelvis/vertebra) are referenced to CT/MRI models, fluoroscopy, 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
- CORUS Navigation Access System (K240625)
- Rialto™ SI Fusion System (K161210)
- Navigated Disc Prep Instruments and CAPSTONE Trials (K150231)
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
May 22, 2026
SurGenTec, LLC
Richard Sharp Jr.
Director of Engineering
911 Clint Moore Rd.
Boca Raton, Florida 33487
Re: K260329
Trade/Device Name: Ion-C Navigation Instruments
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: April 24, 2026
Received: April 24, 2026
Dear Mr. Sharp:
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.
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K260329 - Richard Sharp Jr.
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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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260329 | |
| Device Name Ion-C Navigation Instruments | |
| Indications for Use (Describe) The ION-C Navigation Instruments are intended to be used with the ION-C System Facet Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures, specifically the cervical facet joint, in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medtronic StealthStation System S8, 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 the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy must be used to confirm final implant placement. | |
| 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) | |
| 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 required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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K260329
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510(k) Summary
Device Trade Name: Ion-C Navigation Instruments
Manufacturer: SurGenTec LLC.
911 Clint Moore Road
Boca Raton, FL 33487
Contact: Richard Sharp Jr.
Director of Engineering
(561) 990-7882
Date Prepared: 5/19/2026
Panel: Orthopedic
Common Name: Orthopedic Stereotaxic Instrument
Class: II
Product Codes: OLO
Regulation: 21 CFR 882.4560 (Stereotaxic Instrument)
Primary Predicate: CORUS Navigation Access System (K240625)
Additional Predicate: Rialto™ SI Fusion System (K161210)
Additional Predicate: Navigated Disc Prep Instruments and CAPSTONE Trials, (K150231)
Indications For Use:
The ION-C Navigation Instruments are intended to be used with the ION-C System Facet Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures, specifically the cervical facet joint, in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medtronic StealthStation System S8, 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 the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy must be used to confirm final implant placement.
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K260329
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## Device Description:
The Ion-C Navigation Instruments include locators, a drill, and an inserter. Each Instrument is intended to be used with the Medtronic NavLock Array. The Ion-C Navigation Instruments are provided sterile or non-sterile and are used during the surgical procedure to implant Ion-C System Facet Implants. Specifically, the Ion-C Navigation Instruments are intended to assist the surgeon in locating anatomical structures, specifically the cervical facet joint, in either open or minimally invasive procedures. The Ion-C Navigation Instruments are intended to be used with StealthStation S8.
## Comparison of Technological Characteristics:
The subject Ion-C Navigation Instruments have the same intended use, fundamental scientific technology, critical geometry, materials, and Indications as the predicate devices.
## Performance Testing:
The following tests were conducted to demonstrate substantial equivalence:
- Sterilization Validation per ISO 17664, ISO 11137
- Biocompatibility Assessments per ISO 10993
- Engineering Analyses and Evaluations of Critical Geometry
The subject devices met the pre-determined acceptance criteria for all tests and assessments. The results of all performance testing demonstrates that the Ion-C Navigation Instruments are substantially equivalent to the cited predicate device.
## Substantial Equivalence:
The data presented within the subject 510(k) demonstrates that the Ion-C Navigation Instruments are substantially equivalent to the cited predicate device. The subject and predicate have the same intended use, have the same fundamental scientific technology, critical geometry, and are manufactured from the same material. The results of the performance testing demonstrated that the Ion-C Navigation Instruments are able to perform as intended.
## Conclusion:
Based on the indications for use, technological characteristics, performance testing and comparison to the predicate devices, the Ion-C Navigation Instruments are substantially equivalent to the legally marketed predicate device.
