(25 days)
No
The summary describes a mechanical implant for surgical fixation and does not mention any AI or ML components or functions.
No
The device is described as an implant used for fixation of bone or soft tissue to bone, specifically for repair and reconstruction of ligaments and tendons. This is a structural and mechanical function rather than a therapeutic one (i.e., treating a disease or medical condition).
No
Explanation: The device is described as an implant for fixation of bone or soft tissue to bone, used in various ligament and tendon repairs. Its function is to provide mechanical support and fixation, not to diagnose medical conditions or analyze patient data.
No
The device description clearly states it is comprised of a suture loop, suture button, and passing sutures, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for fixation of bone or soft tissue to bone during surgical procedures (ACL, PCL, MCL repair, etc.). This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a physical implant comprised of sutures and a button, designed for mechanical fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
The device described is a surgical implant used for musculoskeletal repair and reconstruction.
N/A
Intended Use / Indications for Use
The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACLI PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; ITB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The proposed Arthrex TightRope Soft Button, RT is comprised of a suture loop, suture button and passing sutures. The suture loop and passing sutures are braided nonabsorbable surgical sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, soft tissue, ligament, tendon, ACL, PCL, MCL, POL, LCL, ITB, PTR, MPFL, ALL, quadriceps tendon, PLC
Indicated Patient Age Range
adult patient population.
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)
Performance Data: Based on cyclic pull-out testing, the proposed Arthrex TightRope Soft Button, RT device is equivalent to the primary Arthrex ACL Tightrope RC predicate 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.
K112990 – Arthrex ACL TightRope RC, K241235 - Arthrex TightRope II RT
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.
K230976 – Arthrex Radiopaque FiberTape Cerclage sutures
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.
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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large blue letters, and the word "ADMINISTRATION" in smaller blue letters below.
March 11, 2025
Arthrex Inc. Erikka Edwardsen Team Lead Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108
Re: K250424
Trade/Device Name: Arthrex TightRope Soft Button, RT Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 13, 2025 Received: February 14, 2025
Dear Erikka Edwardsen:
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/cdrb/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.
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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).
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 QS 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 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-udi-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-regulatory
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assistance/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,
CHRISTOPHER FERREIRA -S
Christopher Ferriera, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma 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
Submission Number (if known)
K250424
Device Name
Arthrex TightRope Soft Button, RT
Indications for Use (Describe)
The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACLI PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; ITB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.
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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Image /page/4/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word is an image of a surgical instrument, resembling a pair of scissors with a specialized attachment. The logo is simple and modern, and the surgical instrument suggests that the company is involved in the medical field.
510(k) Summary
| Date Prepared | March 11, 2025 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Erikka Edwardsen |
| Title: Team Lead Regulatory Affairs | |
| Phone: 1-239-343-5553, ext. 70422 | |
| Email: rikka.edwardsen@arthrex.com | |
| Trade Name | Arthrex TightRope Soft Button, RT |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fastener |
| Regulatory Class | II |
| Primary Predicate | K112990 – Arthrex ACL TightRope RC |
| Additional Predicate | K241235 - Arthrex TightRope II RT |
| Reference Devices | K230976 – Arthrex Radiopaque FiberTape Cerclage sutures |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the Arthrex TightRope Soft Button, RT as a line extension to previously cleared TightRope devices (K112990, K241235). |
| Device Description | The proposed Arthrex TightRope Soft Button, RT is comprised of a suture loop, suture button and passing sutures. The suture loop and passing sutures are braided nonabsorbable surgical sutures. |
| Indications for Use | The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; ITB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population. |
| Performance Data | Based on cyclic pull-out testing, the proposed Arthrex |
| TightRope Soft Button, RT device is equivalent to the | |
| primary Arthrex ACL Tightrope RC predicate device. | |
| Technological Comparison | The proposed Arthrex TightRope Soft Button, RT device |
| has similar technological characteristics as the primary | |
| predicate and reference devices. The suture used in the | |
| proposed Arthrex TightRope Soft Button, RT device is | |
| identical to legally marketed Arthrex primary predicate | |
| and reference devices. The primary difference between | |
| the subject, primary predicate and reference devices is | |
| that the proposed Arthrex TightRope Soft Button, RT is | |
| manufactured with an all-suture radiopaque button | |
| rather than a titanium button. | |
| Conclusion | Therefore, based on the intended use, fundamental |
| scientific technology, and the data provided in this | |
| Special 510(k), Arthrex has determined that the | |
| proposed Arthrex TightRope Soft Button, RT device in | |
| this submission is substantially equivalent to the | |
| primary predicate and reference devices. Any | |
| differences between the proposed device and the | |
| primary predicate and reference devices are considered | |
| minor and do not raise any new or different questions | |
| concerning safety and effectiveness. |
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Image /page/5/Picture/0 description: The image shows the Arthrex logo. The logo consists of the word "Arthrex" in a sans-serif font, followed by a registered trademark symbol. To the right of the word is an image of a surgical tool, resembling a pair of scissors with a specialized attachment.