Who is the manufacturer of Arthrex TightRope II?

Arthrex, Inc. filed the 510(k) submission for Arthrex TightRope II (K241235).

What is the FDA product code for Arthrex TightRope II?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Arthrex TightRope II?

510(k) clearance (submission type: Special).

What are the predicate devices for Arthrex TightRope II?

Arthrex TightRope II (K231857).

Who can help prepare an FDA 510(k) submission like Arthrex TightRope II?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Arthrex TightRope II

K241235 · Arthrex, Inc. · MBI · May 29, 2024 · Orthopedic

Device Facts

Record ID	K241235
Device Name	Arthrex TightRope II
Applicant	Arthrex, Inc.
Product Code	MBI · Orthopedic
Decision Date	May 29, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

Arthrex TightRope II is a bone fixation fastener system; consists of braided nonabsorbable surgical suture loops and titanium buttons. Used for fixation of bone-to-bone or soft tissue-to-bone; functions as fixation posts or distribution bridges to manage suture tension during ligament or tendon repair. Operated by surgeons in clinical/OR settings. Device provides mechanical stabilization of tissue/bone constructs; facilitates healing by maintaining tension during repair. No electronic or software components.

Clinical Evidence

Bench testing only. Performance supported by cyclic displacement and load displacement testing comparing the subject device to the predicate. No clinical data provided.

Technological Characteristics

Comprised of braided nonabsorbable surgical suture loops and titanium buttons. Mechanical fixation device. No energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for fixation of bone to bone or soft tissue to bone, and as fixation posts or distribution bridges for suture tension in ligament/tendon repair. Patient population includes adults and pediatrics requiring ACL/PCL, MCL, POL, LCL, IBT, PRT, MPFL, ALL, quadriceps tendon, or PLC repair and reconstruction.

Regulatory Classification

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.

Predicate Devices

Arthrex TightRope II (K231857)

Reference Devices

Arthrex TightRope II (K221128)
Arthrex TightRope II (K202581)
Arthrex FiberTak Suture Anchor (K232973)
Arthrex FiberTak Suture Anchor (K232742)
Arthrex FiberTak Suture Anchor (K231113)

Related Devices

K231857 — Arthrex TightRope II · Arthrex, Inc. · Aug 8, 2023
K202581 — Arthrex TightRope II · Arthrex, Inc. · Nov 4, 2020
K110123 — PCL TIGHTROPE · Arthrex, Inc. · Apr 28, 2011
K123341 — ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON · Arthrex, Inc. · Dec 21, 2012
K243470 — Fix2Lock (PEEK Self Punching) · Osteonic Co., Ltd. · Dec 3, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ 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). {1}------------------------------------------------ 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 {2}------------------------------------------------ Enclosure {3}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. # Indications for Use Submission Number (if known) K241235 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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: 1. Medial Patellofemoral Ligament (MPFL) repair and reconstruction 2. Anterolateral Ligament (ALL) repair and reconstruction 3. Quadriceps Tendon repair and reconstruction 4. 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. | {5}------------------------------------------------