(27 days)
The Arthrex TightRope II devices are 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 devices for ACL/ PCL repair and reconstruction for the adult and pediatric patient population; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction.
The proposed Arthrex TightRope II devices are comprised of a suture loop that may include passing sutures and/or metallic button. The suture loop and passing sutures are braided nonabsorbable surgical sutures. The button is made of titanium with hole s to permit suture passage and assembly with Arthrex sutures.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the Arthrex TightRope II device, which outlines the device's indications for use, technological characteristics, and comparison to predicate devices.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, or the number/qualifications of experts used to establish ground truth.
- Information on adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information on standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample sizes for training sets or how their ground truth was established.
The "Performance Data" section briefly states that "Based on cyclic displacement/load displacement testing, the proposed Arthrex TightRope II device is equivalent to the Arthrex TightRope II device predicate device." This indicates that some performance testing was done, but it does not provide the specific criteria or detailed study results. The document focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting detailed performance study data against defined acceptance criteria.
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May 29, 2024
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Arthrex, Inc. Kristi Frisch Regulatory Affairs Specialist, Principal 1370 Creekside Blvd Naples, Florida 34108
Re: K241235
Trade/Device Name: Arthrex TightRope II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 30, 2024 Received: May 2, 2024
Dear Kristi Frisch:
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.
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, Jesse Muir Digitally signed by Date: 2024.05.29 -2 10:45:47 -04'00' Jesse Muir, Ph.D. 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
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Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
Device Name
Arthrex TightRope II
Indications for Use (Describe)
The Arthrex TightRope II devices are 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 devices for ACL/ PCL repair and reconstruction for the adult and pediatric patient population; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction.
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
| Date Prepared | April 30, 2024 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Name: Kristi FrischTitle: Regulatory Affairs, PrincipalPhone: 1-239-598-4302, ext. 73849Email: Kristi.Frisch@Arthrex.com |
| Trade Name | Arthrex TightRope II |
| 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 bonefastener |
| Regulatory Class | II |
| Primary Predicate Device | K231857 Arthrex TightRope II |
| Reference Devices | K221128 Arthrex TightRope IIK202581 Arthrex TightRope IIK232973 Arthrex FiberTak Suture AnchorK232742 Arthrex FiberTak Suture AnchorK231113 Arthrex FiberTak Suture Anchor |
| Purpose of Submission | This Traditional 510(k) premarket notification issubmitted to expand the device indications of theArthrex TightRope II devices previously cleared underK231857, K202581 and K221128 to include:1. Medial Patellofemoral Ligament (MPFL) repair andreconstruction2. Anterolateral Ligament (ALL) repair andreconstruction3. Quadriceps Tendon repair and reconstruction4. Post-Lateral Corner (PLC) repair and reconstruction |
| Device Description | The proposed Arthrex TightRope II devices arecomprised of a suture loop that may include passingsutures and/or metallic button. The suture loop andpassing sutures are braided nonabsorbable surgicalsutures. The button is made of titanium with hole s to |
| permit suture passage and assembly with Arthrexsutures. | |
| Indications for Use | The Arthrex TightRope II devices are intended to beused 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 ligamentor tendon repair. Specifically, Arthrex will be offeringthese devices for ACL/PCL repair and reconstruction forthe adult and pediatric patient population; MCL, POL,LCL repair and reconstruction; IBT and PRT repair; andMPFL, ALL, Quadriceps Tendon, PLC repair andreconstruction. |
| Performance Data | Based on cyclic displacement/load displacementtesting, the proposed Arthrex TightRope II device isequivalent to the Arthrex TightRope II device predicatedevice. This predicate equivalence supports theinclusion of the proposed indications for soft tissuerepairs and reconstructions in the knee for theproposed Arthrex TightRope II devices. |
| Technological Comparison | The proposed Arthrex TightRope II devices haveidentical technological characteristics as the primarypredicate and reference devices. The proposed ArthrexTightRope II devices are comprised of multiple suturesmanufactured using the same materials as thereference device Arthrex FiberTak suture anchor. |
| Conclusion | Therefore, based on the intended use, fundamentalscientific technology, and the data provided in thisSpecial 510(k), Arthrex has determined that theproposed Arthrex TightRope II devices in thissubmission are substantially equivalent to the primarypredicate device Arthrex TightRope II device and thereference device Arthrex FiberTak suture anchor. |
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§ 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.