Arthrex Knotless SutureTak Anchor

K171020 · Arthrex, Inc. · MBI · May 16, 2017 · Orthopedic

Device Facts

• Record ID: K171020
• Device Name: Arthrex Knotless SutureTak Anchor
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: May 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below: • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction • Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction • Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers • 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

Device Story

Arthrex Knotless SutureTak Anchor is a non-absorbable, tap-in bone fixation fastener; manufactured from PEEK; features ribbed profile with proximal external suture eyelet. Device comes preassembled on driver, preloaded with suture. Used by orthopedic surgeons in clinical settings for soft tissue-to-bone fixation across multiple joints (shoulder, knee, hip, etc.). Surgeon inserts anchor into bone; suture secures tissue to anchor. Provides mechanical fixation to facilitate healing of tendons and ligaments. Benefits include stable tissue reattachment and simplified knotless fixation procedure.

Clinical Evidence

Bench testing only. Pull-out testing demonstrated performance statistically equivalent to predicate. Bacterial endotoxin testing per EP 2.6.14/USP <85> confirmed compliance with pyrogen limit specifications.

Technological Characteristics

Material: Polyetheretherketone (PEEK). Design: Non-absorbable, tap-in anchor with ribbed profile and proximal external suture eyelet. Delivery: Preassembled on driver. Sterilization: Not specified.

Indications for Use

Indicated for suture or tissue fixation in foot, ankle, knee, hand, wrist, elbow, shoulder, and hip for patients requiring ligament, tendon, or capsule 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

• DePUY Mitek VERSALOK Anchor (K063478)

Submission Summary (Full Text)

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Arthrex Inc. Mr. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

May, 16, 2017

Re: K171020

Trade/Device Name: Arthrex Knotless SutureTak Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 4, 2017 Received: April 5, 2017

Dear Mr. Rogers:

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 of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ResourcesforYou/Industry/default.htm. 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

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,

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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## 510(k) Summary: K171020

| Date Prepared | March 15, 2017 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | David L Rogers<br>Project Manager, Regulatory Affairs<br>1-239-643-5553, ext. 71924<br>[e-mail] |
| Name of Device | Arthrex Knotless SutureTak Anchor |
| Common Name | Suture Anchor |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K063478: DePUY Mitek VERSALOK Anchor |
| Purpose of<br>Submission | This traditional 510(k) premarket notification is submitted to obtain knee joint<br>capsule closure indications for the Arthrex Knotless SutureTak originally cleared<br>under K120155. |
| Device Description | The Arthrex Knotless SutureTak Anchor is a non-absorbable, "tap-in" suture<br>anchor with a ribbed profile and a proximally placed external suture eyelet. The<br>anchor is manufactured of Polyetheretherketone (PEEK) and is preloaded with<br>Arthrex Suture and is offered preassembled on a driver. The anchor was<br>originally cleared under K120155 for indications in the foot, ankle, knee, hand,<br>wrist, elbow, shoulder, and hip. |
| Indications for Use | The Arthrex Knotless SutureTak Anchor is intended to be used for suture or<br>tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.<br>Specific indications are listed below:<br>• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>Reconstruction<br>• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair,<br>Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction<br>• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament<br>Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of<br>Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits,<br>Digital Tendon Transfers<br>• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon<br>Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital<br>Tendon Transfers, Mid-foot Reconstruction<br>• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair,<br>Iliotibial Band Tenodesis, Joint Capsule Closure<br>• Hip: Capsular Repair, Acetabular Labral repair |
| Performance Data | Pull-out testing was conducted to demonstrate that the Arthrex Knotless<br>SutureTak Anchor performs statistically equivalent to the predicate device. |
| | |
| | Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that<br>the device meets pyrogen limit specifications. |
| <b>Conclusion</b> | The Arthrex Knotless SutureTak Anchor is substantially equivalent to the<br>predicate device in which the basic design features and intended uses are the<br>same. Any differences between the proposed device and the predicate device<br>are considered minor and do not raise questions concerning safety or<br>effectiveness. |
| | Based on the indications for use, technological characteristics, and the summary<br>of data submitted, Arthrex Inc. has determined that the proposed device is<br>substantially equivalent to the currently marketed predicate device. |

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