(42 days)
Not Found
No
The summary describes a mechanical implant system and instruments, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is an implantable system designed for mechanical stabilization and fusion of the sacroiliac joint, rather than delivering therapy.
No
The device is a fusion system designed for the physical stabilization and fixation of the sacroiliac joint, not for identifying or investigating the nature or cause of a condition.
No
The device description explicitly states that the system contains titanium alloy sacroiliac screws and various orthopedic instruments, which are physical hardware components, not software.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the TiLink-L Joint Fusion System is a system of titanium alloy screws and instruments intended for surgical implantation to stabilize the sacroiliac joint.
- Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure, not for analyzing biological samples.
The device is an implantable surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
The TiLink-L Joint Fusion System contains various sized titanium alloy sacroiliac screws for stabilization of the sacroiliac joint. The TiLink-L Joint Fusion System also contains various orthopedic instruments to assist the user in implanting a titanium alloy 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
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 non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicates.
- Torsional strength testing per ASTM F543.
Key Metrics
Not Found
Predicate Device(s)
TiLink-L SI Joint Fusion System- K230446
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.
0
August 3, 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 Andrew Shoup Coo 911 Clint Moore Rd Boca Raton, Florida 33487
Re: K231831
Trade/Device Name: TiLink-L 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: July 6, 2023 Received: July 7, 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2023.08.03 for
08:57:13 -04'00'
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) K231831
Device Name TiLink-L Joint Fusion System
Indications for Use (Describe)
The TiLink-L 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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3
K231831
510(k) Summary
| Device Trade Name: | TiLink-L Joint Fusion System |
|---|---|
| Device Common Name: | Sacroiliac Joint Screw |
| Manufacturer: | 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 | |
| Prepared by: | MCRA, LLC |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 202.552.5800 | |
| Date Prepared: | June 21, 2023 |
| Panel: | Orthopedic |
| Classification Regulation: | II |
| Product Codes: | OUR |
| Class: | 21 CFR 888.3040 |
| Regulation Name: | Smooth or threaded metallic bone |
| fixation fastener | |
| Primary Predicate: | TiLink-L SI Joint Fusion System- |
| K230446 |
Indications For Use:
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Device Description:
The TiLink-L Joint Fusion System contains various sized titanium alloy sacroiliac screws for stabilization of the sacroiliac joint. The TiLink-L Joint Fusion System also contains various orthopedic instruments to assist the user in implanting a titanium alloy sacroiliac implant into the sacroiliac joint to fixate the joint.
4
There are various sacroiliac implant sizes available for implanting to accommodate a range of sacroiliac joint sizes and geometries.
Substantial Equivalence:
The subject TiLink-L Joint Fusion System is substantially equivalent to the TiLink-L Joint Fusion System cleared in K230446 with respect to intended use, materials, design, and function.
Performance Testing:
The following non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicates.
- Torsional strength testing per ASTM F543 .
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 as safe and effective as the predicate device. This data supports that the TiLink-L Joint Fusion System is substantially equivalent to the predicate device.