(180 days)
Not Found
No
The summary describes a mechanical implant and surgical instruments, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for sacroiliac joint fusion to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis, which qualifies it as a therapeutic device.
No
Explanation: The device is an implantable system for sacroiliac joint fusion, designed to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis by transfixing the joint. It is a therapeutic device, not one used to diagnose medical conditions.
No
The device description explicitly states it contains "various orthopedic instruments" and "TiLink Implants" made from "titanium alloy," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the TiLink-P SI Joint Fusion System is an orthopedic device used to implant a titanium implant into the sacroiliac joint to transfix it. This is a surgical procedure performed directly on the body, not an examination of a specimen outside the body.
- Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical treatment, not a diagnostic test.
The device is a surgical implant system, not an IVD.
N/A
Intended Use / Indications for Use
The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.
The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor and along the SI Joint via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint, ilium, sacrum
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical performance data were provided to demonstrate substantial equivalence to the predicate devices.
- Biocompatibility per ISO 10993-1:2018
- Sterilization validation per ISO 17665-1:2006/(R) 2013
- Mechanical static and dynamic testing per ASTM F3574 and ASTM F543
- Side-by-side cadaver study to support performance of device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
September 25, 2023
Image /page/0/Picture/1 description: The image shows the logo for 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Surgentec, LLC Mr. Travis Greenhalgh Chief Executive Officer 911 Clint Moore Rd Boca Raton, Florida 33487
Re: K230857
Trade/Device Name: TiLink-P 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 Dated: September 12, 2023 Received: September 12, 2023
Dear Mr. Travis Greenhalgh:
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 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
1
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 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.
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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
510(k) Number (if known) K230857
Device Name TiLink-P SI Joint Fusion System
Indications for Use (Describe)
The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
| 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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510(k) Summary
| Submitter Information | |
|---|---|
| Submitter: | Surgentec, LLC |
| 911 Clint Moore Rd | |
| Boca Raton, FL 33487 | |
| Telephone: 561-990-7882 | |
| Contact: | Travis Greenhalgh |
| Chief Executive Officer | |
| Telephone: 561-990-7882 | |
| Email: travis@surgentec.com | |
| Date Prepared: | March 28, 2023 |
| Name of Device | |
| Device Proprietary Name: | TiLink-P SI Joint Fusion |
| System | |
| Device Common Name: | Sacroiliac Joint Fixation |
| Classification Regulation: | 21 CFR §888.3040 |
| Class: | II |
| Panel: | Orthopedic |
| Product Code: | OUR |
| Legally Marketed Predicate Device | |
| Primary Predicate: | Catamaran Sacroiliac Joint Fixation System, Tenon |
| Medical, Inc. (K180818) | |
| Secondary Predicate: | SILO TFX MIS Sacroiliac Joint Fixation System, |
| Aurora Spine, Inc. (K221047) |
Device Description
The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint.
The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink implant may be used standalone. The TiLink Implants are manufactured from titanium alloy and include the TiLink Locking Screw and the TiLink Compression Anchor. The TiLink Compression Anchor is designed to transfix the ilium and sacrum while compressing the SI joint. The TiLink Compression Anchor includes an opening to insert the TiLink Locking Screw. During the Procedure, the TiLink
4
Compression Anchor is positioned so that it spans the ilium and sacrum, the TiLink Locking Screw is inserted through the TiLink Compression Anchor and along the SI Joint via a posterior approach. Bone graft material is placed within the TiLink implant to facilitate bone growth.
Indication for Use
The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Technological Characteristics and Substantial Equivalence
The TiLink-P SI Joint Fusion System is substantially equivalent to the primary predicate (Catamaran Sacroiliac Joint Fixation System, K180818) and the secondary predicate (SILO TFX MIS Sacroiliac Joint Fixation System, K221047) devices with respect to indications, design materials, function, and performance.
Performance Data
The following non-clinical performance data were provided to demonstrate substantial equivalence to the predicate devices.
- Biocompatibility per ISO 10993-1:2018 ●
- . Sterilization validation per ISO 17665-1:2006/(R) 2013
- Mechanical static and dynamic testing per ASTM F3574 and ASTM F543 .
- Side-by-side cadaver study to support performance of device ●
Conclusion
The subject device and the predicate devices have the same intended use, technological characteristics, function, and comparable performance. The data included within this submission demonstrate substantial equivalence to the predicate devices listed above.