Arthrex TensionLoc System

K183628 · Arthrex, Inc. · HWC · Mar 26, 2019 · Orthopedic

Device Facts

• Record ID: K183628
• Device Name: Arthrex TensionLoc System
• Applicant: Arthrex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex TensionLoc™ System is indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

Device Story

System consists of two-component PEEK plug and mating collar; used for soft tissue-to-bone fixation in orthopedic procedures. Device inserted into bone tunnel to secure tendons/ligaments. Operated by surgeons in clinical/OR settings. Provides mechanical fixation; replaces traditional metallic fasteners. Benefits include secure soft tissue attachment to bone, facilitating healing.

Clinical Evidence

Bench testing only. Conducted cyclic and ultimate load testing compared to predicate. Biocompatibility testing performed per ISO 10993-1. Sterilization validated per ISO 11135:2014. Bacterial endotoxin testing performed per EP 2.6.14/USP <85>.

Technological Characteristics

Materials: Polyetheretherketone (PEEK). Components: Ribbed outer edge collar and plug. Dimensions: External diameters 11, 14, 16 mm; length 9.1 mm. Sterilization: Ethylene Oxide (ISO 11135:2014).

Indications for Use

Indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

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

• Acufex® Washer System (K994202)

Reference Devices

• Arthrex Short Suture Anchors (K151092)
• Interference Screws (K062466)
• Arthrex RetroButton (K062747)

Submission Summary (Full Text)

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March 26, 2019

Arthrex Inc. Stacy Valdez Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K183628

Trade/Device Name: Arthrex TensionLocTM System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 18. 2018 Received: December 26, 2018

Dear Stacy Valdez:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Laurence D. Coyne -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K183628

Device Name Arthrex TensionLocTM System

Indications for Use (Describe)

The Arthrex TensionLoc™ System is indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

| 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 | December 18, 2018 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Stacy Valdez<br>Senior Regulatory Affairs Associate<br>1-239-643-5553, ext. 72010<br>[e-mail] |
| Name of Device | Arthrex TensionLocTM System |
| Common Name | Screw, Fixation, Bone |
| Product Code | HWC |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K994202: Acufex® Washer System<br><br>K151092: Arthrex Short Suture Anchors (Reference)<br>K062466: Interference Screws (Reference)<br>K062747: Arthrex RetroButton (Reference) |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for<br>the Arthrex TensionLocTM System |
| Device Description | The Arthrex TensionLocTM System is a two-component system comprised of a<br>polyetheretherketone (PEEK) plug and a mating collar for suture fixation within a<br>bone tunnel.<br><br>The primary differences between the Arthrex TensionLocTM System and the<br>predicate device are the geometry and material. The proposed Arthrex<br>TensionLocTM System contains a ribbed outer edge collar and plug as opposed to<br>the predicate geometry of a double spiked plate and cannulated post. The<br>Arthrex TensionLocTM System is also manufactured of PEEK material whereas the<br>predicate is manufactured from titanium. The Arthrex Tension LocTM System will<br>offer external diameters of 11, 14, and 16 as opposed to the 13-22 mm range of<br>the predicate. The Arthrex TensionLocTM System is 9.1 mm in length as opposed<br>to the various lengths of the predicate (24-40 mm). |
| Indications for Use | The Arthrex TensionLocTM System is indicated for fixation of soft tissue, such as<br>tendons and ligaments to bone in orthopedic procedures. |
| Performance Data | Cyclic and ultimate load testing was conducted and compared to the predicate<br>device.<br><br>Biocompatibility testing was conducted in accordance with the requirements of<br>ISO 10993-1 Biological Evaluation of Medical Devices: Evaluation and testing<br>within a risk management process.<br><br>Sterilization validation has been conducted in accordance with ISO 11135:2014<br>Sterilization of health-care products – Ethylene Oxide – Requirements for the<br>development, validation, and routine control of a sterilization process for medical<br>devices. |
| | Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that<br>the device meets pyrogen limit specifications. |
| Conclusion | The Arthrex TensionLoc™ System is substantially equivalent to the predicate<br>device in which the intended use, sterility, and fundamental scientific technology<br>are the same. Any differences between the proposed device and the predicate<br>device are considered minor and do not raise questions concerning safety or<br>effectiveness. |
| | The submitted mechanical testing data demonstrates that the performance of<br>the proposed devices meets or exceeds the predicate device for the desired<br>indications. |
| | Based on the indications for use, technological characteristics, and the summary<br>of data submitted, Arthrex Inc. has determined that the Arthrex TensionLoc™ System is substantially equivalent to the currently marketed predicate device. |

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