Arthrex FiberTak Suture Anchor

K200341 · Arthrex, Inc. · MBI · Mar 12, 2020 · Orthopedic

Device Facts

• Record ID: K200341
• Device Name: Arthrex FiberTak Suture Anchor
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 12, 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, 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 • Hip: Acetabular labral repair.

Device Story

Arthrex FiberTak Suture Anchor is an all-suture soft-tissue fixation device; used for reattaching soft tissue to bone in various orthopedic procedures (shoulder, knee, hip, etc.). Device consists of hollow polyester braid anchor preloaded with UHMWPE or UHMWPE/polyester blend suture on a disposable inserter. Operation involves surgeon inserting anchor into bone; new self-punching inserter and self-bunching mechanism facilitate deployment. Device is single-use and sterile. Output is secure fixation of soft tissue to bone, aiding healing and structural stability. Used in clinical settings by orthopedic surgeons.

Clinical Evidence

Bench testing only. Ultimate load and pyrogenicity testing performed on representative devices compared to predicate to demonstrate substantial equivalence.

Technological Characteristics

All-suture anchor constructed from hollow polyester braid; suture component composed of UHMWPE or UHMWPE/polyester polyblend. Features self-punching disposable inserter and self-bunching mechanism. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip orthopedic procedures. Applicable to patients requiring ligament, tendon, or labral repair/reconstruction.

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 FiberTak Suture Anchor (K181769)

Reference Devices

• Arthrex FiberTak DR Suture Anchor (K160319)

Submission Summary (Full Text)

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March 12, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K200341

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: February 4, 2020 Received: February 11, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 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, PhD Acting 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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## Indications for Use

510(k) Number (if known)

## K200341

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, 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

· Hip: Acetabular labral repair.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <span style="padding-right:5px;"> <b> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right:5px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

| Date Prepared | March 10, 2020 |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Jessica L. Singelais<br>Regulatory Affairs Specialist<br>1-239-598-4302, ext. 73091<br>[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 | K181769: Arthrex FiberTak Suture Anchor |
| Reference Device | K160319: Arthrex FiberTak DR Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the<br>self-punching Arthrex FiberTak Suture Anchor as a line extension to the Arthrex<br>FiberTak Suture Anchor devices cleared under K181769. |
| Device Description | The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be<br>used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee,<br>hand/wrist, elbow, and hip.<br><br>The anchor is constructed from a hollow braid of polyester with a single or double<br>loaded suture component composed of UHWMPE or a polyblend of UHMWPE and<br>polyester. The anchor is preloaded on a disposable inserter and will be sold sterile for<br>single use. |
| Indications for Use | The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft<br>tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the<br>following procedures:<br>Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>ReconstructionShoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift<br>or Capsulolabral ReconstructionHand/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<br>Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint<br>arthroplasty)Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,<br>Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon<br>transfers, Mid-foot reconstructionKnee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,<br>Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band<br>TenodesisHip: Acetabular labral repair. |
| Comparison<br>Summary of<br>Technological | The proposed device is a line extension to the predicate device. The proposed and<br>predicate devices (K181769) have the same basic design, intended use, indications for<br>use, packaging, shelf life and sterilization method. Proposed modifications consist of |
| Characteristics and<br>Modifications<br>Proposed | a self-punching inserter and self-bunching mechanism. Any differences between the<br>proposed device and the predicate device are considered minor and do not raise<br>questions concerning safety or effectiveness. |
| Performance Data | Ultimate load and pyrogenicity testing was conducted on a representative device and<br>compared to the predicate device to demonstrate that the proposed devices are<br>substantially equivalent to the predicate. |
| Conclusion | The proposed Arthrex FiberTak Suture Anchors are substantially equivalent to the<br>predicate device in which the basic design features and intended uses are the same.<br>Any differences between the proposed device and the predicate device are<br>considered minor and do not raise questions concerning safety or effectiveness.<br>Based on the indications for use, technological characteristics, and the summary of<br>data submitted, Arthrex Inc. has determined that the Arthrex FiberTak is substantially<br>equivalent to the currently marketed predicate device. |

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