(30 days)
The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The purpose of this Special 510(k) is to introduce the TiLink-P with Window variant to the TiLink-P SI Joint Fusion System. The Window feature is designed to promote osteointegration.
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-P implants may be used standalone. The TiLink-P SI Joint Fusion System fixates the sacroiliac joint by transfixing the cortices of the ilium and cortices of the sacrum.
The TiLink-P Compression Anchor is positioned so that it spans the cortices of ilium and cortices of sacrum, the TiLink-P Locking Screw is inserted through the TiLink-P Compression Anchor and along the SI Joint via a posterior approach, in order to compress the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.
The FDA letter provided is a clearance letter for a medical device (TiLink-P SI Joint Fusion System), not an AI/ML device. Therefore, the document does not contain information about acceptance criteria or studies pertaining to AI/ML device performance. The information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is not applicable to the content of this document.
The document discusses the substantial equivalence of the "TiLink-P SI Joint Fusion System" to a predicate device (TiLink-P Joint Fusion System K240720) through mechanical strength tests.
Here is the information that is available in the document:
1. A table of acceptance criteria and the reported device performance
The document states that performance testing was conducted according to specific ASTM standards to demonstrate substantial equivalence to the predicate device. However, it does not provide a table of acceptance criteria (e.g., specific thresholds for pullout strength or shear strength) nor the reported numerical performance data. It only lists the types of tests performed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document (Implied: To be substantially equivalent to predicate device as measured by ASTM F543 and ASTM F3574) | "demonstrates substantial equivalence to the predicate device." |
| Axial Pullout per ASTM F543 | Testing performed |
| Static and Dynamic Vertical Shear per ASTM F3574 | Testing performed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The "test set" here refers to physical devices for mechanical testing, not a dataset for an AI/ML model. The document does not specify the number of devices tested. Data provenance such as country of origin or retrospective/prospective is not relevant for this type of device clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is derived from established engineering principles and ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for resolving disagreements among human experts in labeling datasets, which is not relevant for mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a clearance for a physical medical implant, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For mechanical testing, the "ground truth" is provided by the established ASTM standards and the physical properties and performance of the predicate device.
8. The sample size for the training set
Not applicable. There is no AI/ML model, and therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model, and therefore no training set or ground truth for a training set.
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Image /page/0/Picture/0 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.
August 21, 2024
SurGenTec, LLC Berny Villejeune Official Correspondent 911 Clint Moore Rd Boca Raton, Florida 33487
Re: K242141
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: July 19, 2024 Received: July 22, 2024
Dear Berny Villejeune:
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"
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(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 product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS 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 (QS) 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 mediation-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.
STEPHANIE SMITH -S
For Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
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Indications for Use
Submission Number (if known)
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)
| 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: | SurGenTec, LLC911 Clint Moore RdBoca Raton, FL 33487Phone: 561-990-7882Email: bryan@surgentec.com |
|---|---|
| Official Correspondent: | Mr. Berny VillejeuneEngineering ManagerSurGenTec, LLC911 Clint Moore RdBoca Raton, FL 33487Phone: 561-409-1494Email: berny@surgentec.com |
| Date Prepared: | July 22, 2024 |
| Trade Name: | TiLink-P SI Joint Fusion System |
| Common Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | II21 CFR 888.3040 |
| Product Code: | OUR |
| Predicate Device: | TiLink-P Joint Fusion System (K240720) |
Device Description:
The purpose of this Special 510(k) is to introduce the TiLink-P with Window variant to the TiLink-P SI Joint Fusion System. The Window feature is designed to promote osteointegration.
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-P implants may be used standalone. The TiLink-P SI Joint Fusion System fixates the sacroiliac joint by transfixing the cortices of the ilium and cortices of the sacrum.
The TiLink-P Compression Anchor is positioned so that it spans the cortices of ilium and cortices of sacrum, the TiLink-P Locking Screw is inserted through the TiLink-P Compression Anchor and along the SI Joint via a posterior approach, in order to compress
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the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.
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.
Substantial Equivalence:
The subject TiLink-P with Window SI Joint Fusion System is substantially equivalent to the previously cleared version in K240720 with respect to intended use, materials, design, and function.
Performance Testing:
The following tests have been performed on the TiLink-P with Window SI Joint Fusion System:
- Axial Pullout per ASTM F543
- . Static and Dynamic Vertical Shear per ASTM F3574.
Through these mechanical strength tests the TiLink-P SI Joint Fusion System with Window demonstrates substantial equivalence to the predicate device.
§ 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.