Arthrex SwiveLock Anchors

K151342 · Arthrex, Inc. · MAI · Mar 24, 2016 · Orthopedic

Device Facts

• Record ID: K151342
• Device Name: Arthrex SwiveLock Anchors
• Applicant: Arthrex, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Mar 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex SwiveLock anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization. Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair and Bunionectomy. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only). Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair. Hip: Capsular repair, acetabular labral repair

Device Story

Two-component, knotless suture anchor system; consists of eyelet and hollow anchor body; pre-mounted on driver. Used by orthopedic surgeons in clinical settings for soft tissue-to-bone fixation. Device secures suture to bone; facilitates tissue reattachment or reconstruction. Provides mechanical fixation; aids in healing by maintaining tissue position. Benefits include stable fixation for various orthopedic repairs.

Clinical Evidence

Bench testing only. Biomechanical testing (ultimate load) performed to validate the device's performance as secondary fixation in ACL reconstruction.

Technological Characteristics

Two-component knotless suture anchor; includes eyelet and hollow anchor body; pre-mounted on driver. Mechanical fixation device. Materials not specified in text. No software or electronic components.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip orthopedic procedures, including ligament/tendon repairs and reconstructions. Includes secondary fixation for ACL/PCL reconstruction (4.75-5.5mm sizes).

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Arthrex SwiveLock Anchors (K101823)
• Arthrex Bio Interference Screws (K071176)

Submission Summary (Full Text)

{0}------------------------------------------------

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, abstract style.

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

March 24, 2016

Arthrex, Incorporated Mr. David Rogers Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K151342 Trade/Device Name: Arthrex SwiveLock Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: February 19, 2016 Received: February 23, 2016

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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" (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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K151342

Device Name Arthrex SwiveLock Anchors

Indications for Use (Describe)

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

· Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

· Foot/Ankle: Lateral Stabilization. Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair and Bunionectomy.

· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).

• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

· Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

· Hip: Capsular repair, acetabular labral repair

| Type of Use ( <i>Select one or both, as applicable</i> ) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><span style="padding-right:5px">☒</span>Prescription Use (Part 21 CFR 801 Subpart D) </td><td><span style="padding-right:5px">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span style="padding-right:5px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right:5px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="padding-right:5px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right:5px">☐</span> 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510K SUMMARY OF SAFETY AND EFFECTIVENESS

| Date Summary Prepared | November 18, 2015 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/<br>Distributor/<br>Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | David L Rogers<br>Regulatory Affairs<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 71924<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex SwiveLock Anchors |
| Common Name | Suture Anchor |
| Product Code, | MAI, MBI |
| Classification Name, CFR | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances<br>and accessories |
| Predicate Device | K101823: Arthrex SwiveLock Anchors<br>K071176: Arthrex Bio Interference Screws |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to include an additional<br>indication for secondary fixation in ACL/PCL reconstruction or repair for the<br>Arthrex SwiveLock Anchors (4.75 - 5.5 sizes). |
| Device Description | The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor<br>comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-<br>mounted on a driver with the anchor body and eyelet physically separated on the<br>driver shaft. FiberWire suture may also be provided with the device. |
| Intended Use | The Arthrex SwiveLock anchors are intended for fixation of suture (soft tissue) to<br>bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the<br>following procedures:<br>Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair,<br>Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction.Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon<br>Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction,<br>Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and<br>Illiotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction<br>or repair (4.75 – 5.5 SwiveLock only).Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial<br>Collateral Ligament Reconstruction.Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or<br>Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.Hip: Capsular repair, acetabular labral repair. |
| Substantial<br>Equivalence Summary | The Arthrex SwiveLock Anchors are substantially equivalent to the predicate<br>devices, in which the basic design features and intended uses are the same. Any<br>differences between the Arthrex SwiveLock Anchors and the predicates are<br>considered minor and do not raise questions concerning safety and effectiveness.<br>Biomechanical testing (ultimate load) was conducted to demonstrate that the use<br>of the SwiveLock as a secondary fixation in ACL reconstruction is greater than a<br>construct without it. |

{4}------------------------------------------------

Based on the indication for use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that the **Arthrex SwiveLock Anchors** is substantially equivalent to currently marketed predicate devices.