Arthrex Syndesmosis TightRope XP Buttress Plate Implant System

K201522 · Arthrex, Inc. · HTN · Sep 3, 2020 · Orthopedic

Device Facts

• Record ID: K201522
• Device Name: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
• Applicant: Arthrex, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Sep 3, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Device Story

System provides syndesmotic fixation during healing; consists of 2-hole buttress plate (titanium alloy or stainless steel), two knotless TightRopes (titanium alloy buttons, UHMWPE braid suture), and disposable inserter. Used in orthopedic surgery; operated by surgeons. Implanted to stabilize syndesmosis disruptions in Weber B/C ankle fractures. Provides mechanical fixation; replaces or supplements traditional screw fixation. Benefits include stable fixation during bone healing process. Provided sterile, single-use.

Clinical Evidence

Bench testing only. Includes cyclic fatigue testing, MRI safety testing (force, torque, image artifact, RF heating per ASTM F2052, F2119, F2182, F2213), bacterial endotoxin testing (ANSI/AAMI ST72, USP <161>, USP <85>), and biocompatibility testing (ISO 10993-1:2018 including cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, and implantation).

Technological Characteristics

Materials: Titanium alloy or stainless steel plate, titanium alloy buttons, UHMWPE suture. Form factor: 2-hole buttress plate with knotless suture-button construct. MR Conditional. Sterilization: Sterile, single-use. No software or active energy source.

Indications for Use

Indicated for fracture repair of metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external/intramedullary fixation systems. Specifically indicated for syndesmosis disruption fixation in Weber B and C ankle fractures.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Arthrex TightRope Syndesmosis Devices (K043248)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

September 3, 2020

Arthrex Inc. Rebecca R. Homan Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108

Re: K201522

Trade/Device Name: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HTN Dated: June 4, 2020 Received: June 8, 2020

Dear Ms. Homan:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

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 (QS) 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 medical devices and radiation-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,

Laura C. Rose, 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

510(k) Number (if known)

K201522

Device Name

Arthrex Syndesmosis TightRope XP Buttress Plate Implant System

Indications for Use (Describe)

The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <div> <span> <b> × </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

## 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 [e-mail]

"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 | September 3, 2020 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 |
| Contact Person | Rebecca R. Homan |
| | Regulatory Affairs Specialist |
| | 1-239-643-5553, ext. 73429 |
| | [e-mail] |
| Name of Device | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System |
| Common Name | Button/Suture |
| Product Code | HTN |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| | and accessories |
| Regulatory Class | II |
| Predicate Device | K043248: Arthrex TightRope Syndesmosis Devices |
| Purpose of | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| Submission | the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System. |
| Device Description | The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System consists of |
| | one 2 Hole Syndesmosis Buttress Plate (titanium alloy), two Knotless TightRopes |
| | (titanium alloy buttons and UHMWPE braid suture) and various ancillary |
| | instruments to aid in insertion. The proposed Arthrex Buttress Plate is a metal |
| | plate is manufactured from either titanium alloy or stainless steel. The |
| | implantable devices are packaged with various ancillary instruments to aid in |
| | insertion. The implantable devices and various ancillary instruments are provided |
| | sterile and are single use. |
| Indications for Use | The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended |
| | as an adjunct in fracture repair involving metaphyseal and periarticular small |
| | bone fragments where screws are not indicated, and as an adjunct in external |
| | and intramedullary fixation systems involving plates and rods, with fracture |
| | braces and casting. |
| | Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System |
| | is intended to provide fixation during the healing process following a syndesmotic |
| | trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection |
| | with Weber B and C ankle fractures. |
| Performance Data | Cyclic fatigue testing was conducted to demonstrate that the proposed Arthrex |
| | Syndesmosis TightRope XP Buttress Plate Implant System performs statistically…