Arthrex TightRope II

K231857 · Arthrex, Inc. · MBI · Aug 8, 2023 · Orthopedic

Device Facts

• Record ID: K231857
• Device Name: Arthrex TightRope II
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Aug 8, 2023
• Decision: SESE
• Submission Type: Traditional
• 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 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; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.

Device Story

Arthrex TightRope II consists of braided nonabsorbable surgical suture loop, passing sutures, and titanium button; used for bone/soft tissue fixation. Device functions as fixation post or tension distribution bridge during ligament/tendon repair. Operated by surgeons in clinical/OR settings. Provides mechanical fixation; output is physical stabilization of tissue/bone. Benefits include secure ligament/tendon repair. No software or algorithm involved.

Clinical Evidence

Bench testing only. Cyclic displacement and strength testing performed to demonstrate equivalence to predicate device.

Technological Characteristics

Comprised of braided nonabsorbable surgical sutures and titanium button. Mechanical fixation device. No energy source, software, or connectivity.

Indications for Use

Indicated for fixation of bone-to-bone or soft tissue-to-bone; fixation posts; distribution bridge; suture tension distribution for ligament/tendon repair. ACL/PCL repair/reconstruction (adult/pediatric); MCL, POL, LCL repair/reconstruction, IBT, and PRT (adults only).

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

• Zimmer Biomet ToggleLoc (K130033)

Reference Devices

• Arthrex TightRope II (K221128)
• Arthrex TightRope II (K202581)

Submission Summary (Full Text)

{0}------------------------------------------------

August 8, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.

Arthrex Inc. Kristi Frisch Regulatory Affairs, Principal 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K231857

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: June 21, 2023 Received: June 23, 2023

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 (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 located 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.

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

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jesse Muir -S

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

Enclosure

{2}------------------------------------------------

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K231857

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; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> 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."

{3}------------------------------------------------

## 510(k) Summary

| Date Prepared | June 21, 2023 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 |
| Contact Person | Name: Kristi Frisch |
| | Title: Regulatory Affairs, Principal |
| | Phone: [phone], ext. 73849 |
| | Email: [e-mail] |
| 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<br>fastener |
| Regulatory Class | II |
| Primary Predicate Device | K130033 Zimmer Biomet ToggleLoc™ |
| Reference Devices | K221128 Arthrex® TightRope II |
| | K202581 Arthrex® TightRope II |
| Purpose of Submission | This Traditional 510(k) premarket notification is<br>submitted to expand the device indications to include<br>(for the adult population only):<br>1. Medial Collateral Ligament (MCL) Repair and<br>Reconstruction;<br>2. Posterior Oblique Ligament (POL) Repair and<br>Reconstruction;<br>3. Lateral Collateral Ligament (LCL) Repair and<br>Reconstruction;<br>4. Iliotibial Band Tenodesis (IBT); and<br>5. Patella Tendon Repair (PTR) for the Arthrex<br>TightRope II devices cleared under K202581 and<br>K221128 |
| Device Description | The Arthrex TightRope II devices are comprised of a<br>suture loop that may include passing sutures and/or<br>metallic button. The suture loop and passing sutures<br>are braided nonabsorbable surgical sutures. The button<br>is made of titanium with holes to permit suture passage<br>and assembly with Arthrex sutures. |
| Indications for Use | The Arthrex TightRope II devices are intended to be<br>used for fixation of bone to bone or soft tissue to bone,<br>and are intended as fixation posts, a distribution bridge,<br>or for distributing suture tension over areas of ligament |
| | or tendon repair. Specifically, Arthrex will be offering<br>these devices for ACL/PCL repair and reconstruction for<br>the adult and pediatric patient population; and MCL,<br>POL, LCL repair and reconstruction, IBT, and PRT for the<br>adult population only. |
| Performance Data | Based on cyclic displacement and strength testing, the<br>proposed Arthrex TightRope II device is equivalent to<br>the predicate Zimmer-Biomet ToggleLoc™ device. This<br>predicate equivalence supports the inclusion of the<br>proposed indications for soft tissue repairs and<br>reconstructions in the knee for the proposed Arthrex<br>TightRope II devices. |
| Technological Comparison | The proposed Arthrex TightRope II devices have similar<br>technological characteristics as the predicate devices.<br>The proposed device is comprised of multiple sutures<br>manufactured using the same materials as the<br>reference predicate. |
| Conclusion | Therefore, based on the intended use, fundamental<br>scientific technology, and the data provided in this<br>Special 510(k), Arthrex has determined that the<br>proposed Arthrex TightRope II devices in this<br>submission are substantially equivalent to the reference<br>predicate Arthrex TightRope II devices and the<br>performance of the Zimmer-Biomet ToggleLoc<br>predicate devices. |

{4}------------------------------------------------