TiLink-L™ SI Joint Fusion System
Device Facts
| Record ID | K261381 |
|---|---|
| Device Name | TiLink-L™ SI Joint Fusion System |
| Applicant | SurGenTec, LLC |
| Product Code | OUR · Orthopedic |
| Decision Date | Aug 24, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The TiLink-L Navigation Instruments are intended to be used with the TiLink-L Joint Fusion System during 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, 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 is intended to be used for navigating final implant placement.
Device Story
System provides minimally invasive stabilization of sacroiliac joint; transfixes ilium and sacrum; provides joint compression/fixation. Implants: titanium; nanotex surface; self-drilling/self-tapping; cannulated with graft windows for bone graft delivery via GraftGun or pusher/funnel. Navigation instruments: used with Medtronic StealthStation S8; assist surgeon in locating anatomical structures; enable navigation of implant placement via CT/MRI/fluoroscopy/digitized landmarks. Used in OR; operated by surgeons. Benefits: controlled fusion across joint; precise implant placement.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via bench testing: static torsion, driving torque, axial pullout (ASTM F543); static/dynamic 3/4-point bending (ASTM F1264); navigational accuracy assessments; sterilization, packaging, and shelf-life validation; and biocompatibility (ISO 10993-1).
Technological Characteristics
Titanium implants with nanotex surface; self-drilling/self-tapping design; cannulated for bone graft delivery. Navigation instruments compatible with Medtronic StealthStation S8. Testing per ASTM F543 (torsion, torque, pullout), ASTM F1264 (bending), and ISO 10993-1 (biocompatibility).
Indications for Use
Indicated for adults (22+ years) requiring sacroiliac joint fusion due to sacroiliac joint disruptions or degenerative sacroiliitis. Navigation instruments are indicated for use with the Medtronic StealthStation System S8 to assist in locating anatomical structures during open or minimally invasive procedures.
Regulatory Classification
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
- TiLink-L Joint Fusion System (K231831)
Reference Devices
- TiLink-L Navigation Instruments (K253604)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG
ADMINISTRATION
August 24, 2026
SurGenTec, LLC
Marcel Eugene
Engineer I
911 Clint Moore Rd.
Boca Raton, Florida 33487
Re: K261381
Trade/Device Name: TiLink-L™ SI Joint Fusion System
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class: Class II
Product Code: OUR, OLO
Dated: May 26, 2026
Received: May 26, 2026
Dear Marcel Eugene:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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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,
# STEPHANIE SMITH -S
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
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| 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. | K261381 | ? |
| Please provide the device trade name(s). | | ? |
| TiLink-L™ SI Joint Fusion System | | |
| Please provide your Indications for Use below. | | ? |
| The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The TiLink-L Navigation Instruments are intended to be used with the TiLink-L Joint Fusion System during 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, 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 is intended to be used for navigating final implant placement. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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# 510(k) Summary
**Device Trade Name:** TiLink-L™ SI Joint Fusion System
**Manufacturer:** SurGenTec LLC.
911 Clint Moore Road
Boca Raton, FL 33487
**Contact:** Gui Pires
VP of Operations
SurGenTec LLC.
561-990-7882
**Date Prepared:** August 21, 2026
**Panel:** Orthopedic
**Class:** II
**Product Codes:** OUR, OLO
**Regulation:** 21 CFR 888.3040
**Primary Predicate:** TiLink-L Joint Fusion System (K231831)
**Reference Device:** TiLink-L Navigation Instruments (K253604)
### Indications For Use:
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The TiLink-L Navigation Instruments are intended to be used with the TiLink-L Joint Fusion System during 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, 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 is intended to be used for navigating final implant placement.
### Device Description:
The purpose of this submission is to add an additional implant configuration (TiLink-L Helix) and a navigation instrument to the TiLink-L SI Joint Fusion System.
The TiLink-L SI Joint Fusion System is designed to provide controlled, minimally invasive stabilization of the sacroiliac joint. TiLink features a low profile design that transfixes the ilium and sacrum while providing joint compression and fixation. TiLink-L implants are manufactured from titanium and contain nanotex surface technology. The TiLink-L
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Implants incorporate a self drilling, self tapping design to facilitate controlled insertion. Integrated graft windows within the cannulated screw enable delivery of bone graft (autogenous and/or allogeneic bone graft) with the TiLink-L Graft Pusher / Funnel or SurGenTec's GraftGun to support to support fusion across the joint.
The TiLink-L Navigation Instruments are specifically designed to be used with the TiLink-L Joint Fusion System Implants. The TiLink-L Navigation Instruments are to be used with the NavLock Instruments and Medtronic StealthStation System S8.
### **Comparison of Technological Characteristics:**
The subject TiLink-L Joint Fusion System has the same intended use, fundamental scientific technology, material, and critical dimensions as the predicate devices.
### **Performance Testing:**
The following tests were conducted to demonstrate substantial equivalence:
- Static Torsion per ASTM F543
- Driving Torque per ASTM F543
- Axial Pullout per ASTM F543
- Static and Dynamic three / four-point bending per ASTM F1264
- Navigational Accuracy Assessments
- Sterilization Validation
- Packaging Validation
- Shelf-life Validation
- Biocompatibility Assessments per ISO 10993-1
The subject devices met the pre-determined acceptance criteria for all tests and assessments. The results of all performance testing demonstrates that the TiLink-L Joint Fusion System is substantially equivalent to the cited predicate device.
### **Substantial Equivalence:**
The data presented within the subject 510(k) demonstrates that the TiLink-L Joint Fusion System is substantially equivalent to the cited predicate device. The subject and predicate have the same intended use, have the same fundamental scientific technology, and are manufactured from the same material. The results of the performance testing demonstrated that the TiLink-L Navigation Instruments are able to perform as intended and are substantially equivalent to the predicate device.
### **Conclusion:**
Based on the indications for use, technological characteristics, performance testing and comparison to the predicate device and reference device, the TiLink-L Joint Fusion System is substantially equivalent to the legally marketed predicate device.
