Arthrex FiberTak Anchors

K151230 · Arthrex, Inc. · MBI · Jun 19, 2015 · Orthopedic

Device Facts

• Record ID: K151230
• Device Name: Arthrex FiberTak Anchors
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jun 19, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex FiberTak Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below: • 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

Device Story

All-suture soft-tissue fixation device; expandable push-in design. Anchor and sutures impacted into pilot hole; manual tensioning causes suture sleeve to bulge, securing anchor within bone. Once set, suture passed through soft tissue and tied in knot to complete repair. Used in orthopedic surgical procedures (e.g., rotator cuff, ligament reconstruction) by surgeons. Provides mechanical fixation of soft tissue to bone; facilitates healing by maintaining tissue approximation. Modifications include updated predrilling instructions, new drilling instruments, double-loaded configurations, and new suture components.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated pull-out strength meeting or exceeding predicate device; pull-out displacements were within acceptable criteria.

Technological Characteristics

All-suture anchor; hollow braid of polyester with UHMWPE or UHMWPE/polyester blend suture component. Disposable inserter made of surgical grade nitinol and ABS plastic. Sterile, single-use. Mechanical fixation via expansion/bulging mechanism.

Indications for Use

Indicated for patients requiring soft tissue or suture fixation in the elbow, shoulder, hand/wrist, foot/ankle, and knee for various ligamentous, tendinous, and capsular repairs/reconstructions.

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 (K140476)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2015

Arthrex, Incorporated Ms. Ivette Galmzez Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K151230

Trade/Device Name: Arthrex FiberTak Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Class: Class II Product Code: MBI Dated: May 20, 2015 Received: May 21, 2015

Dear Ms. Galmez:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Mark N. Melkerson -S

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

510(k) Number (if known)

K151230 Device Name

Arthrex FiberTak Anchors

Indications for Use (Describe)

The Arthrex Fiber Tak Anchors are intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

· 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 PP, 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 Repart, 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

2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) 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:

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Type of Use (Select one or both, as applicable)

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## 2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Date Summary Prepared | June 19, 2015 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/<br>Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Ivette Galmez<br>Regulatory Affairs Specialist<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 71263<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex FiberTak Anchors |
| Common Name | Soft Tissue Fixation Device |
| Product Code -<br>Classification Name<br>CFR | MBI<br>Fastener, fixation, nondegradable, soft tissue<br>21 CFR 888.3040 |
| Predicate Device | K140476: Arthrex FiberTak Suture Anchor |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain<br>clearance for the Arthrex FiberTak Anchors. The Arthrex FiberTak<br>Anchors include modifications to predrilling instructions and<br>drilling instruments, new double loaded configurations and new<br>suture components. |
| Device Description | The Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation<br>devices with an expandable push-in design. The anchor and<br>connected sutures are impacted into a pilot hole. The sutures are<br>then manually tensioned to set the anchor by "bulging" the<br>suture sleeve within the pilot hole. Once the anchor is set, the<br>suture is passed around the soft tissue and tied in a knot to<br>complete the repair. |
| | The FiberTak anchor is constructed from a hollow braid of<br>polyester with a suture component assembled through the<br>hollow braid. The suture component can be comprised of<br>UHWMPE or a polyblend of UHMWPE and Polyester. The anchor<br>comes preloaded on a disposable inserter made from surgical<br>grade nitinol and ABS plastic. The Arthrex FiberTak Anchors may<br>be sold separately or in a kit with implantation instrumentation.<br>The Arthrex FiberTak Anchors are provided sterile for single use. |
| Intended Use | The Arthrex FiberTak Anchors are intended to be used for suture<br>or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and<br>shoulder. Specific indications are listed below: |
| | • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral<br>Ligament Reconstruction |
| | • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion<br>Repair, Biceps Tenodesis, Acromio-Clavicular Separation<br>Repair, Deltoid Repair, Capsular Shift or Capsulolabral<br>Reconstruction |
| | • Hand/Wrist: Scapholunate Ligament Reconstruction,<br>Repair/Reconstruction of collateral ligaments, Repair of Flexor<br>and Extensor Tendons at the PIP, DIP and MCP joints for all<br>digits, digital tendon transfers, Carpal Ligament Reconstruction<br>and Carpometacarpal joint arthroplasty (basal thumb joint<br>arthroplasty) |
| | • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles<br>Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus<br>reconstruction, digital tendon transfers, Mid-foot<br>reconstruction |
| | • Knee: Medial Collateral Ligament Repair, Lateral Collateral<br>Ligament Repair, Patellar Tendon Repair, Posterior Oblique<br>Ligament Repair, Iliotibial Band Tenodesis |
| Substantial Equivalence<br>Summary | The proposed Arthrex FiberTak Anchors are similar to the<br>predicate device, in which the basic design features, materials<br>and intended uses are the same. |
| | The submitted mechanical testing demonstrates that the pull-out<br>strength of the proposed Arthrex FiberTak Anchors meet or<br>exceed the pull out strength of the predicate device. In addition,<br>the pull out displacements recorded were found to meet the<br>criteria established by the predicate devices and therefore of no<br>clinical relevance. Furthermore, the biocompatibility and<br>packaging/shelf life for the new suture component were<br>reviewed and determined to be acceptable due to its similarities<br>in material and packaging. |
| | Based on the indication for use, the technological characteristics,<br>and the summary of data submitted, Arthrex, Inc. has<br>determined that the Arthrex FiberTak Anchors is substantially<br>equivalent to currently marketed predicate devices. |

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