(27 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to a predicate device, with no mention of AI or ML.
Yes
The device is intended for the fixation of bone or soft tissue to bone, and for distributing suture tension over areas of ligament or tendon repair, specifically for various knee repairs and reconstructions. These uses directly address and aim to treat a medical condition or ailment, which defines a therapeutic device.
No
The device is described as a fixation device for bone or soft tissue repair and reconstruction, not for diagnosis. It is intended to fix tissues, not to identify or characterize medical conditions.
No
The device description explicitly states the device is comprised of a suture loop and a metallic button, indicating it is a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The Arthrex TightRope II devices are described as surgical implants used for fixing bone or soft tissue to bone within the body during surgical procedures. They are used for repair and reconstruction of ligaments and tendons.
The information provided clearly indicates that this device is an implantable surgical device used in vivo (within the body), not an in vitro diagnostic device used for testing specimens outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
MBI
Device Description
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 holes to permit suture passage and assembly with Arthrex sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric 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)
Based on cyclic displacement/load displacement testing, the proposed Arthrex TightRope II device is equivalent to the Arthrex TightRope II device predicate device. This predicate equivalence supports the inclusion of the proposed indications for soft tissue repairs and reconstructions in the knee for the proposed Arthrex TightRope II devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K231857 Arthrex TightRope II
Reference Device(s)
K221128 Arthrex TightRope II, K202581 Arthrex TightRope II, K232973 Arthrex FiberTak Suture Anchor, K232742 Arthrex FiberTak Suture Anchor, K231113 Arthrex FiberTak Suture Anchor
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.
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May 29, 2024
Image /page/0/Picture/1 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 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.
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
3
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 Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Kristi Frisch |
| Title: Regulatory Affairs, Principal | |
| Phone: 1-239-598-4302, ext. 73849 | |
| Email: 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 bone |
| fastener | |
| Regulatory Class | II |
| Primary Predicate Device | K231857 Arthrex TightRope II |
| Reference Devices | K221128 Arthrex TightRope II |
| K202581 Arthrex TightRope II | |
| K232973 Arthrex FiberTak Suture Anchor | |
| K232742 Arthrex FiberTak Suture Anchor | |
| K231113 Arthrex FiberTak Suture Anchor | |
| Purpose of Submission | This Traditional 510(k) premarket notification is |
| submitted to expand the device indications of the | |
| Arthrex TightRope II devices previously cleared under | |
| K231857, K202581 and K221128 to include: |
- Medial Patellofemoral Ligament (MPFL) repair and
reconstruction - Anterolateral Ligament (ALL) repair and
reconstruction - Quadriceps Tendon repair and reconstruction
- Post-Lateral Corner (PLC) repair and reconstruction |
| Device Description | 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. |
| Indications for Use | The Arthrex TightRope II devices are 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 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. |
| Performance Data | Based on cyclic displacement/load displacement
testing, the proposed Arthrex TightRope II device is
equivalent to the Arthrex TightRope II device predicate
device. This predicate equivalence supports the
inclusion of the proposed indications for soft tissue
repairs and reconstructions in the knee for the
proposed Arthrex TightRope II devices. |
| Technological Comparison | The proposed Arthrex TightRope II devices have
identical technological characteristics as the primary
predicate and reference devices. The proposed Arthrex
TightRope II devices are comprised of multiple sutures
manufactured using the same materials as the
reference device Arthrex FiberTak suture anchor. |
| 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 II devices in this
submission are substantially equivalent to the primary
predicate device Arthrex TightRope II device and the
reference device Arthrex FiberTak suture anchor. |
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