(106 days)
Not Found
No
The device description and performance studies focus on mechanical and biocompatibility aspects of a surgical implant and instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is intended for sacroiliac joint fusion to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis, which directly addresses disease or injury.
No
The device is an implantable system for joint fusion, not for diagnosing medical conditions. Its purpose is to fixate the sacroiliac joint, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it contains "various orthopedic instruments" and a "titanium sacroiliac implant," indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the TiLink-L Joint Fusion System contains instruments and implants used to fixate the sacroiliac joint within the body. This is an implantable surgical device, not a device that analyzes samples outside the body.
- Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, based on the provided information, the TiLink-L Joint Fusion System is a surgical implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
The TiLink-L Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to fixate the joint. There are various sacroiliac implant sizes available for implanting to accommodate a range of sacroiliac joint sizes and geometries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sacroiliac joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical treatment
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)
Non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicates:
- Biocompatibility per ISO 10993-1:2018
- Sterilization validation per ISO 17665-1:2006/(R) 2013
- Mechanical static and dynamic testing per ASTM F543 and ASTM F1264
- V/V Mechanical and Safety Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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June 7, 2023
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Surgentec, LLC Andrew Shoup Chief Operating Officer 911 Clint Moore Rd Boca Raton, Florida 33487
Re: K230446
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 Dated: March 10, 2023 Received: March 10, 2023
Dear Andrew Shoup:
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
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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.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Eileen Cadel. The date of the signature is 2023.06.07 and the time is 08:45:23 -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
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Indications for Use
510(k) Number (if known) K230446
Device Name TiLink-L SI Joint Fusion System
Indications for Use (Describe)
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.
| 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) |
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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: | Andrew Shoup |
| Chief Operating Officer | |
| Telephone: 561-990-7882 | |
| Email: ashoup@surgentec.com | |
| Date Prepared: | February 1, 2023 |
| Name of Device | |
| Device Proprietary Name: | TiLink-L SI Joint Fusion System |
| Device Common Name: | Sacroiliac Joint Screw |
| Classification Regulation: | Class II; 21 CFR 888.3040 |
| Regulation Name: | Smooth or threaded metallic bone fixation fastener |
| Panel: | Orthopedic |
| Product Code: | OUR |
| Legally Marketed Predicate Device | |
| Primary Predicate: | SI-LOK SACROILIAC JOINT FIXATION SYSTEM |
| GLOBUS MEDICAL, INC. | |
| 510(k) number: K112028 | |
| Additional Predicate: | SIJFuse™ Sacroiliac Joint Fusion Device System |
| SpineFrontier, Inc. | |
| 510(k) number: K150017 |
Device Description
The TiLink-L Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to fixate the joint. There are various sacroiliac implant sizes available for implanting to accommodate a range of sacroiliac joint sizes and geometries.
Indication for Use
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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Technological Characteristics and Substantial Equivalence
The subject TiLink-L Joint Fusion System is substantially equivalent to the predicate SIJFuse™ Sacroiliac Joint Fusion Device System previously cleared in 510k K150017 and the SI-LOK SACROILIAC JOINT FIXATION SYSTEM previously cleared in 510k K112028. Both devices are contained in a device tray containing the required components to action the device, not provided sterile but can be sterilized via steam sterilization prior to use and are intended for surgical treatment of the sacroiliac joint. All characteristics and indications between the TiLink-L Joint Fusion System and the predicates are the same, therefore the subject device is substantially equivalent to the predicate devices.
Performance Data
The following non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicates.
- Biocompatibility per ISO 10993-1:2018 ●
- Sterilization validation per ISO 17665-1:2006/(R) 2013
- Mechanical static and dynamic testing per ASTM F543 and ASTM F1264 ●
- V/V Mechanical and Safety Testing .
Conclusion
The design characteristics of the TiLink-L Joint Fusion System does not raise different questions of safety and effectiveness. Non-clinical study data supports that the device is substantially equivalent to predicate devices. This data supports that the TiLink-L Joint Fusion System is substantially equivalent to the predicate device.