ARTHREX FIBERTAK SUTURE ANCHOR

K140476 · Arthrex, Inc. · MBI · Aug 13, 2014 · Orthopedic

Device Facts

• Record ID: K140476
• Device Name: ARTHREX FIBERTAK SUTURE ANCHOR
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Aug 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex FiberTak Suture Anchor is 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, Iliotail Band Tenodesis

Device Story

All-suture soft-tissue fixation device; expandable push-in design. Anchor and sutures impacted into pilot hole; manual tensioning of sutures causes anchor sleeve to bulge, securing it within bone. Surgeon then passes suture around soft tissue and ties knot to complete repair. Used in orthopedic procedures (foot/ankle, knee, hand/wrist, elbow, shoulder) by surgeons. Device provided sterile for single use; preloaded on disposable inserter. Benefits include secure tissue-to-bone fixation for various orthopedic reconstructions.

Clinical Evidence

Bench testing only; pull-out strength testing performed to demonstrate mechanical equivalence to the predicate device.

Technological Characteristics

Anchor constructed from hollow polyester braid; suture comprised of UHMWPE and polyester. Inserter made of surgical grade nitinol and ABS plastic. Mechanical fixation via suture-based expansion (bulging) mechanism. Sterile, single-use device.

Indications for Use

Indicated for patients requiring suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder for various ligament, tendon, and joint 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 MicroSuture Anchor (K112237)

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.

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

August 13, 2014

Arthrex, Incorporated Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108

Re: K140476

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: July 24, 2014 Received: July 28, 2014

Dear Ms. Smith:

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,

# Lori A. Wiggins

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

Enclosure

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### 2.5 INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-01 Expiration Date: December 31, 201 See PRA Statement on last page.

510(k) Number (if known)

K140476

Device Name

#### Arthrex FiberTak Suture Anchor

Indications for Use (Describe)

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

- o 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

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Page 1/1

FORM FDA 3881 (9/13)

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# 2.2 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Date Summary Prepared | April 21, 2014 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 USA |
| 510(k) Contact | Courtney Smith |
| | Regulatory Affairs Manager |
| | Arthrex, Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 USA |
| | Telephone: [phone], ext. 1720 |
| | Fax: [phone] |
| | Email: [e-mail] |
| Trade Name | Arthrex FiberTak Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Product Code -Classification Name | MBI |
| CFR | Fastener, fixation, nondegradable, soft tissue |
| | 21 CFR 888.3040 |
| Predicate Device | K112237: Arthrex MicroSuture Anchor |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted<br>to obtain clearance for the Arthrex FiberTak Suture<br>Anchor. |
| Device Description | The Arthrex FiberTak Suture Anchor is an "all-suture"<br>soft-tissue fixation device with an expandable push-in<br>design. The anchor and connected sutures are impacted<br>into a pilot hole. The sutures are then manually<br>tensioned to set the anchor by "bulging" the suture<br>sleeve within the pilot hole. Once the anchor is set, the<br>suture is passed around the soft tissue and tied in a knot<br>to complete the repair.<br>The device is provided sterile intended for single use. The |
| | anchor is constructed from a hollow braid of polyester. A<br>blue and white striped suture comprised of UHMWPE<br>(white) and Polyester (blue) is assembled through the<br>hollow braid. The striped suture component is<br>designated as TigerWire CL. The device comes preloaded<br>on a disposable inserter. The inserter is made from<br>surgical grade nitinol and ABS plastic. The FiberTak<br>Suture may be sold separately or in a kit with<br>implantation instrumentation. |
| Intended Use | The Arthrex FiberTak Suture Anchor is intended to be<br>used for suture or tissue fixation in the foot/ankle, knee,<br>hand/wrist, elbow, and shoulder. Specific indications are<br>listed below:<br>• Elbow: Biceps Tendon Reattachment, Ulnar or Radial<br>Collateral Ligament Reconstruction<br>• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP<br> |
| Substantial Equivalence Summary | The indications for use of the proposed Arthrex FiberTak<br>Suture Anchor are identical to the predicate device.<br>The submitted mechanical testing demonstrates that the<br>pull-out strength of the proposed devices meets or<br>exceeds the pull-out strength of the predicate devices.<br>Based on the indication for use, technological<br>characteristics, and the summary of data submitted,<br>Arthrex, Inc. has determined that the FiberTak Suture<br>Anchor is substantially equivalent to currently marketed<br>predicate devices. |

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