The TiLink-P Joint Fusion System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

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-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 across the SI Joint via a lateral approach, compressing the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "TiLink-P Joint Fusion System." The purpose of these notifications is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.

The type of "device" in question here is a system of orthopedic implants and instruments used for sacroiliac joint fusion. This is a physical medical device, not software or an AI algorithm. Therefore, the questions related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/software device do not apply to this document.

The document describes performance testing for the physical device, which involves mechanical tests to ensure its structural integrity and functionality, rather than clinical performance based on an AI model's output.

Here's why the AI/software-related questions cannot be answered from this document:

No AI or Software Component: The 510(k) summary explicitly describes the TiLink-P Joint Fusion System as "various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant" and "TiLink Implants and associated Instruments." There is no mention of any AI, machine learning, or software component that would require assessment of diagnostic accuracy, image performance, or human-AI collaboration.
Focus on Substantial Equivalence: The entire premise of a 510(k) is to prove substantial equivalence to a predicate device. This typically involves comparing indications for use, technological characteristics, materials, and mechanical performance for physical devices. It does not involve evaluating "device performance" in terms of diagnostic accuracy or impact on human readers, which are typical for AI/software clearances.
Performance Testing Summary: The "Performance Testing Summary" lists "Axial Pullout Testing per ASTM F543," "Torsional Properties per ASTM F543-17," and "Static and Dynamic Cantilever Test per ASTM F3574." These are all standard mechanical tests for orthopedic implants, ensuring they can withstand physiological loads. They are not studies of algorithm performance.

Therefore, I cannot provide answers to the questions you've asked because they are tailored for AI/software-based medical devices, and the provided document describes a physical orthopedic implant system.

Summary

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November 21, 2024

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SurGenTec LLC Gui Pires VP of Operations 911 Clint Moore Rd Boca Raton, Florida 33487

Re: K242414

Trade/Device Name: TiLink-P 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: October 29, 2024 Received: October 30, 2024

Dear Gui Pires:

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" (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).

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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.

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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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-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).

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Sincerely,

Ethan R. Naylor -S

For Ronal 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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242414

Device Name

TiLink-P Joint Fusion System

Indications for Use (Describe)

The TiLink-P Joint Fusion System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

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

Device Trade Name:	TiLink-P Joint Fusion System
Manufacturer:	Surgentec, LLC911 Clint Moore RdBoca Raton, FL 33487Telephone: 561-990-7882
Contact:	Gui PiresVP of OperationsTelephone: 561-990-7882Email: gui@surgentec.com
Date Prepared:	November 21, 2024
Classifications:	21 CFR §888.3040
Class:	II
Product Codes:	OUR
Primary Predicate:	TiLink-P Joint Fusion System, SurGenTec, LLC (K240720)

Indications For Use:

The TiLink-P Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description:

Predicate Device:

SurGenTec, LLC. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, TiLink-P Joint

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Fusion System is substantially equivalent in indications, design principles, and performance to the following predicate devices:

Primary Predicate: TiLink-P Joint Fusion System (K240720)

Performance Testing Summary:

The subject TiLink-P SI Joint Fusion System has been assessed via the following testing:

Axial Pullout Testing per ASTM F543
Torsional Properties per ASTM F543-17
Static and Dynamic Cantilever Test per ASTM F3574 ●

Substantial Equivalence:

The TiLink-P Joint Fusion System is substantially equivalent to the primary predicate (TiLink-P Joint Fusion System, K240720) device with respect to indications, design materials, function, and performance.

Conclusion:

The subject device and the predicate devices have intended use, have the same technological characteristics, and are made of the same materials. The subject and predicate devices are packaged in same materials and are sterilized using same methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. The TiLink-P Joint Fusion System is as safe, as effective, and performs as well as, or better, than the predicate devices.

Regulation Number and Section

§ 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.