(227 days)
The Ion-C System facet implants are intended to be placed bilaterally through a posterior surgical approach and spans the facet joint interspace. The Ion-C is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. The Ion-C is indicated for patients requiring a revision for an anterior pseudoarthrosis at one or two contiguous levels, from C3 to C7. The Ion-C is only intended to be used in combination with an FDA-cleared anterior cervical plate and intervertebral body fusion device implanted at the same level(s). The Ion-C is intended for use with autogenous and/or allogenic bone graft.
Ion-C is intended for bilateral stabilization of the facets from C3-C7 at 1- or 2-contiguous levels. Ion-C is intended to be placed bilaterally through a posterior approach and is intended to span the facet joint interspace.
Ion-C is designed for controlled non-impact placement to minimize damage to the implant and anatomy. Ion-C offers controlled implant depth by allowing in situ depth adjustment. The Ion-C offers a zero profile implant design which includes fenestrations and open barrels allow for bone graft integration and fusion. When Ion-C is implanted the joint is kept in a neutral position, reducing the risk of joint expansion. Ion-C engagement features are designed to resist implant expulsion.
Ion-C includes various types of Implants, which can be provided sterile or non-sterile. All Implants are manufactured from Ti6Al4V per ASTM F136. The Ion-C Instruments are offered in various configurations, including single-use (provided sterile), and reusable (provided non-sterile). The Ion-C Instruments may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of bone graft.
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FDA 510(k) Clearance Letter - Ion-C Device
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
January 16, 2026
SurGenTec LLC
Guilherme Pires
Vice President of Operations
911 Clint Moore Rd
Boca Raton, Florida 33487
Re: K251714
Trade/Device Name: Ion-C
Regulatory Class: Unclassified
Product Code: MRW
Dated: October 27, 2025
Received: October 28, 2025
Dear Guilherme Pires:
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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K251714 - Guilherme Pires Page 2
(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 (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 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.
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-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).
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K251714 - Guilherme Pires Page 3
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E.
Assistant Director
DHT6B: Division of Spinal Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251714
Please provide the device trade name(s).
Ion-C
Please provide your Indications for Use below.
The Ion-C System facet implants are intended to be placed bilaterally through a posterior surgical approach and spans the facet joint interspace. The Ion-C is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. The Ion-C is indicated for patients requiring a revision for an anterior pseudoarthrosis at one or two contiguous levels, from C3 to C7. The Ion-C is only intended to be used in combination with an FDA-cleared anterior cervical plate and intervertebral body fusion device implanted at the same level(s). The Ion-C is intended for use with autogenous and/or allogenic bone graft.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Ion-C Page 8 of 34
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510(k) Summary
Submitter: SurGenTec, LLC
911 Clint Moore Rd
Boca Raton, FL 33487
Phone: 561-990-7882
Email: gui@surgentec.com
Official Correspondent: Mr. Guilherme Pires
Vice President of Operations
SurGenTec, LLC
911 Clint Moore Rd
Boca Raton, FL 33487
Phone: 561-990-7882
Email: gui@surgentec.com
Date Prepared: January 12, 2026
Trade Name: Ion-C
Common Name: Facet Spinal Device
Classification Name: Unclassified
Product Code: MRW
Primary Predicate Device: PMT Facet Fixation System (PMT FFS) (K220951)
Additional Predicate: Ion 3D (K241416, K243265, K240086, K211855)
Device Description:
Ion-C is intended for bilateral stabilization of the facets from C3-C7 at 1- or 2-contiguous levels. Ion-C is intended to be placed bilaterally through a posterior approach and is intended to span the facet joint interspace.
Ion-C is designed for controlled non-impact placement to minimize damage to the implant and anatomy. Ion-C offers controlled implant depth by allowing in situ depth adjustment. The Ion-C offers a zero profile implant design which includes fenestrations and open barrels allow for bone graft integration and fusion. When Ion-C is implanted the joint is kept in a neutral position, reducing the risk of joint expansion. Ion-C engagement features are designed to resist implant expulsion.
Ion-C includes various types of Implants, which can be provided sterile or non-sterile. All Implants are manufactured from Ti6Al4V per ASTM F136. The Ion-C Instruments are offered in various configurations, including single-use (provided sterile), and reusable (provided non-sterile). The Ion-C Instruments may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of bone graft.
K251714
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Indications for Use:
Ion-C is intended to be placed bilaterally through a posterior surgical approach and spans the facet joint interspace. The Ion-C is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. The Ion-C is indicated for patients requiring a revision for an anterior pseudoarthrosis at one or two contiguous levels, from C3 to C7. The Ion-C is only intended to be used in combination with an FDA-cleared anterior cervical plate and intervertebral body fusion device implanted at the same level(s). The Ion-C is intended for use with autogenous and/or allogenic bone graft.
Technological Similarities and Differences
The Ion-C Implants and the predicate PMT Facet Fixation System are both intended to be placed in the facet joint interspace for temporary stabilization as an adjunct to fusion in patients requiring a revision for anterior pseudoarthrosis. The Ion-C is intended to be used at 1- or 2-contiguous levels whereas the PMT Facet Fixation System is intended to be used at 1-level. The Ion-C and PMT Facet Fixation System are both manufactured from titanium. The Ion-C is provided either sterile or non-sterile, while the PMT Facet Fixation System is provided sterile only.
Substantial Equivalence:
Retrospective clinical data on the subject device were provided in support of this submission. The clinical outcomes demonstrated the Ion-C to have substantially equivalent safety and effectiveness profile compared to predicates when treating the same patient population.
The totality of data provided on the Ion-C, including non-clinical and clinical evaluations, demonstrated that the technological characteristics do not raise different questions of safety and effectiveness and the Ion-C is substantially equivalent to the PMT Facet Fixation System.
Performance Testing of the Ion-C:
The following tests have been performed on the Ion-C:
- Biocompatibility assessment per ISO 10993
- Sterilization validations
- Shelf-Life evaluations
- Static and Dynamic Three Point Bend Testing per ASTM F1264
- Axial Pushout Testing per ASTM F543
- Static Compression Bending per ASTM F1264
- Torque to Failure Testing per ASTM F543
- Insertion and Removal Torque Testing per F543
- Retrospective clinical data has been provided on the Ion-C and compared to the predicate device as well as other cervical fusion techniques utilizing dynamic radiographic and CT evaluations.
The totality of performance testing on the Ion-C demonstrated substantial equivalence to the PMT Facet Fixation System.
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Conclusion:
The information provided in this submission supports the conclusion that the Ion-C is substantially equivalent to the predicate devices.
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