FiberTak Suture Anchor

K230568 · Arthrex, Inc. · MBI · Apr 1, 2023 · Orthopedic

Device Facts

• Record ID: K230568
• Device Name: FiberTak Suture Anchor
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Apr 1, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FiberTak suture anchors are intended to be used for suture or tissue fixation in the foot, ankle, wrist, elbow, shoulder, and hip. · Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction · Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction · Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) · Foot Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction · Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure · Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.

Device Story

FiberTak Suture Anchors are all-suture implants designed for soft tissue-to-bone fixation; used by orthopedic surgeons in clinical settings. Device functions as a mechanical fastener to secure tendons or ligaments to bone. Operates via standard surgical techniques for orthopedic repair. Benefits include secure tissue fixation to facilitate healing. No electronic or software components.

Clinical Evidence

Bench testing only. Performance data included ultimate load testing and cyclic displacement to verify mechanical strength. Bacterial endotoxin testing performed per USP <85> to confirm compliance with pyrogen limit specifications.

Technological Characteristics

All-suture anchor design; utilizes same materials as predicate devices. Mechanical fixation principle. No energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for patients requiring soft tissue to bone fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip for various ligamentous and tendon repairs.

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 Knotless FiberTak (K203268)

Reference Devices

• Arthrex Knotless FiberTak (K203268)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

April 1, 2023

Arthrex Inc. Erikka Edwardsen Regulatory Affairs Principal Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K230568

Trade/Device Name: FiberTak Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 28, 2023 Received: March 1, 2023

Dear Erikka Edwardsen:

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

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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,

## Sara S. Thompson -S

For

Laurence D. Coyne, Ph.D. 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

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## Indications for Use

510(k) Number (if known)

K230568

Device Name

FiberTak Suture Anchor

Indications for Use (Describe)

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The FiberTak suture anchors are intended to be used for suture or tissue fixation in the foot, ankle, wrist, elbow, shoulder, and hip.

· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

· Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

· Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

· Foot Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

· Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure

· Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="text-decoration: overline;">☑</span> 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 | February 27, 2023 | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 | |
| Contact Person | Erikka Edwardsen<br>Regulatory Affairs Principal Specialist<br>1-239-643-5553, ext. 70422<br>[e-mail] | |
| Name of Device | FiberTak Suture Anchor | |
| Common Name | Fastener, Fixation, Nondegradable, Soft Tissue | |
| Product Code | MBI | |
| Classification Name | 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener. | |
| Regulatory Class | II | |
| Predicate Device | K203268 Arthrex Knotless FiberTak® | |
| Reference Device | K203268 Arthrex Knotless FiberTak® | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for<br>two (2) new FiberTak® Suture Anchors as a line extension to previously cleared<br>Arthrex FiberTak® devices (K203268) | |
| Device Description | The Arthrex FiberTak® Suture Anchors are all-suture anchors intended to be used<br>for soft tissue to bone fixation. | |
| Indications for Use | The FiberTak suture anchors are intended to be used for suture or tissue<br>fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.<br><br>• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>Reconstruction<br><br>• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift<br>or Capsulolabral Reconstruction<br><br>• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of<br>collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and<br>MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction<br>and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)<br><br>• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,<br>Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon<br>transfers, Mid-foot reconstruction<br><br>• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,<br>Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band<br>Tenodesis, Joint Capsule Closure | |
| | | • Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.. |
| Summary of<br>Technological<br>Characteristics | | The proposed devices have similar technological characteristics as the predicate<br>devices. The subject device is comprised of multiple sutures manufactured using<br>the same materials as the predicate. |
| Performance Data | | Ultimate load testing and cyclic displacement was performed on the subject<br>device to demonstrate that the differences do not negatively impact mechanical<br>strength.<br>Bacterial endotoxin per USP <85> was conducted to demonstrate that the device<br>meets pyrogen limit specifications. |
| Conclusion | | The Arthrex FiberTak® Implants are substantially equivalent to the predicate<br>devices in which the basic design features, intended use and surgical technique<br>are the same. Any differences between the subject device and the predicate<br>devices do not raised questions concerning safety and effectiveness.<br>Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is<br>substantially equivalent to the currently marketed predicate devices. |

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