Not Found
No
The document describes a surgical implant (facet screw) and associated instruments for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests of the device itself.
Yes
The device is a medical implant (Ion 3D Facet Screw) used in spinal fusion surgery to treat conditions like spondylolisthesis and degenerative disc disease, which are therapeutic interventions.
No
The device is a surgical implant (facet screw) used for posterior spinal fusion. Its indications for use describe the conditions it treats, not conditions it diagnoses.
No
The device description explicitly states it contains "various sized facet screws" and is manufactured from "Ti6Al4V per ASTM F136," indicating it is a physical implant and not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or to monitor health. Examples include blood tests, urine tests, and genetic tests.
- The Ion 3D Facet Screw is a surgical implant. It is a device that is surgically placed into the body to provide stabilization for the spine.
The provided text clearly describes a surgical implant and its intended use in posterior spinal fusion. There is no mention of examining specimens or performing diagnostic tests.
N/A
Intended Use / Indications for Use
The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse and for the delivery of hydrated allograft or autograft.
The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:
- · Spondylolisthesis
- · Spondylolysis
- · Pseudoarthrosis or failed previous fusions which are symptomatic
· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).
Product codes
MRW, FMW, HTR
Device Description
The Ion 3D contains various sized facet screws with and without graft windows, for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-S1 (inclusive) spinal levels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following tests have been performed on the Ion 3D.
- Axial pushout testing and torsional properties per ASTM F543
- Static and Dynamic three-point bend testing per ASTM F1264
Key Metrics
Not Found
Predicate Device(s)
Ion 3D (K240086)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
June 17, 2024
Image /page/0/Picture/1 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SurGenTec, LLC Bryan Hellriegel Vice President of Product Development 911 Clint Moore Rd. Boca Raton, Florida 33487
Re: K241416 Trade/Device Name: Ion 3D Regulatory Class: Unclassified Product Code: MRW, FMW, HTR Dated: May 17, 2024 Received: May 17, 2024
Dear Bryan Hellriegel:
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" (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
1
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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Digitally ileen signed by Eileen Cadel -S ade Date: 2024.06.17 15:57:11 -04'00' for 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
2
Indications for Use
510(k) Number (if known) K241416
Device Name Ion 3D
Indications for Use (Describe)
The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse and for the delivery of hydrated allograft or autograft.
The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:
- · Spondylolisthesis
- · Spondylolysis
- · Pseudoarthrosis or failed previous fusions which are symptomatic
· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Submitter: | SurGenTec, LLC
911 Clint Moore Rd
Boca Raton, FL 33487
Phone: 561-990-7882
Email: bryan@surgentec.com |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Mr. Bryan Hellriegel
Vice President of Product Development
SurGenTec, LLC
911 Clint Moore Rd
Boca Raton, FL 33487
Phone: 561-990-7882
Email: bryan@surgentec.com |
| Date Prepared: | June 14, 2024 |
| Trade Name: | Ion 3D |
| Common Name: | Facet Screw Spinal Device, Piston Syringe and Bone Rasp |
| Classification: | Unclassified
21 CFR 880.5860 |
| Product Code: | MRW, FMF, HTR |
| Primary Predicate Device: | Ion 3D (K240086) |
Purpose of Submission:
The purpose of this submission is to expand the Ion 3D product listing to include variants of the Ion 3D facet screws with graft windows.
Device Description:
The Ion 3D contains various sized facet screws with and without graft windows, for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.
Indications for Use:
The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft.
The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2- S1 (inclusive) spinal levels for the following:
4
- Spondylolisthesis ●
- Spondylolysis ●
- Pseudoarthrosis or failed previous fusions which are symptomatic ●
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin with ● degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).
Substantial Equivalence:
The subject Ion 3D Facet Screw with graft windows is substantially equivalent to the previously cleared version in K240086 with respect to intended use, materials, design, and function.
Performance Testing:
The following tests have been performed on the Ion 3D.
- Axial pushout testing and torsional properties per ASTM F543 ●
- Static and Dynamic three-point bend testing per ASTM F1264 ●
Conclusion:
Based on the performance testing, the subject device is determined to be substantially equivalent to the primary predicate device.