Arthrex FiberTak Suture Anchor

K203268 · Arthrex, Inc. · MBI · Nov 27, 2020 · Orthopedic

Device Facts

• Record ID: K203268
• Device Name: Arthrex FiberTak Suture Anchor
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Nov 27, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion 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 Collateral 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

All-suture anchor device; consists of hollow polyester braid with UHMWPE or UHMWPE/polyester polyblend suture. Preloaded on disposable inserter; sterile for single use. Used by surgeons in orthopedic procedures (shoulder, knee, hip, etc.) to secure soft tissue to bone. Operates via mechanical fixation; anchor bunches upon deployment to provide secure attachment point. Enables reattachment of tendons and ligaments; facilitates surgical repair; promotes healing by maintaining tissue position. No electronic or software components.

Clinical Evidence

Bench testing only. Cyclic pull-out testing compared subject device to predicate (K200341) and reference devices (K133671, K171020) to validate performance for new indications. Bacterial endotoxin testing performed per EP 2.6.14/USP <85> to confirm compliance with pyrogen limits.

Technological Characteristics

All-suture anchor; hollow polyester braid; UHMWPE or UHMWPE/polyester polyblend suture. Mechanical fixation via self-bunching mechanism. Sterile, single-use, disposable inserter. No energy source, software, or connectivity.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip procedures. Applicable to patients requiring ligament/tendon repair or reconstruction, including rotator cuff, biceps, Achilles, and capsular 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 Self-punching FiberTak Suture Anchor (K200341)
• Arthrex SutureTak Suture Anchor (K171020)

Reference Devices

• Stryker ICONIX All Suture Anchor System (K133671)
• Arthrex Corkscrew and SwiveLock Suture Anchors (K143745)
• Arthrex SwiveLock Suture Anchor (K191226)

Submission Summary (Full Text)

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November 27, 2020

Image /page/0/Picture/1 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

Arthrex Inc. Jessica L. Singelais Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108

Re: K203268

Trade/Device Name: Arthrex 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: October 30, 2020 Received: November 5, 2020

Dear Ms. Singelais:

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/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 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,

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

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Special 510ßEPARTMENT 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)

K203268

Device Name Arthrex FiberTak Suture Anchor

#### Indications for Use (Describe)

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

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

· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion 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 Collateral 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="font-size: 10px;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10px;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart C) </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 | November 19, 2020 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 |
| Contact Person | Jessica L. Singelais |
| | Senior Regulatory Affairs Specialist |
| | 1-239-598-4302, ext. 73091 |
| | [e-mail] |
| Name of Device | Arthrex FiberTak Suture Anchor |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K200341: Arthrex Self-punching FiberTak Suture Anchor |
| | K171020: Arthrex SutureTak Suture Anchor |
| Reference Device(s) | K133671: Stryker ICONIX All Suture Anchor System |
| | K143745: Arthrex Corkscrew and SwiveLock Suture Anchors<br>K191226: Arthrex SwiveLock Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to expand indications for the<br>Arthrex FiberTak Suture Anchor devices cleared under K200341 to include Gluteal |
| | Tendon Repair, Capsular Repair (Hip), and Joint Capsule Closure (Knee). |
| Device Description | The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be |
| | used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, |
| | hand/wrist, elbow, and hip. |
| | The anchor is constructed from a hollow braid of polyester with a single loaded |
| | suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. |
| | The anchor is preloaded on a disposable inserter and will be sold sterile for single use. |
| Indications for Use | The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft |
| | tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the |
| | following procedures: |
| | Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair. |

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| Comparison<br>Summary of<br>Technological<br>Characteristics and<br>Modifications<br>Proposed | The proposed device is a line extension to the predicate device. The proposed and<br>predicate device (K200341) have the same basic design, intended use, packaging,<br>shelf life, biocompatibility profile and sterilization method. Proposed modifications<br>consist of a minor dimensional change to the self-bunching mechanism and the<br>addition of gluteal tendon and joint capsule closure (knee) indications. Any<br>differences between the proposed device and the predicate device are considered<br>minor and do not raise questions concerning safety or effectiveness. |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | Cyclic pull-out testing was performed on the subject device and compared to the<br>Arthrex FiberTak predicate device. Results demonstrate that the Arthrex FiberTak<br>Anchor performs statistically equivalent to the predicate device. Results were<br>compared to K133671: Stryker Iconix All Suture Anchor System and K171020: Arthrex<br>SutureTak Suture Anchor to show suitability for the gluteal tendon repair and joint<br>capsule closure (knee) indications, respectively.<br>Bacterial endotoxin per EP 2.6.14/USP <85> was conducted on a representative<br>device to demonstrate that<br>the device meets pyrogen limit specifications. |
| Conclusion | The Arthrex FiberTak Suture Anchor is substantially equivalent to the predicate device<br>in which the basic design features and intended use are the same. Any differences<br>between the Arthrex proposed device and the predicate device are considered minor<br>and do not raised questions concerning safety and effectiveness. Based on the<br>indications for use, technological characteristics, and the summary of data submitted,<br>Arthrex Inc. has determined that the proposed device is substantially equivalent to<br>the currently marketed predicate device. |