ARTHREX SWIVELOCK ANCHORS

K101823 · Arthrex, Inc. · MAI · Jan 7, 2011 · Orthopedic

Device Facts

• Record ID: K101823
• Device Name: ARTHREX SWIVELOCK ANCHORS
• Applicant: Arthrex, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Jan 7, 2011
• 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 Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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

SwiveLock Anchor is a two-component, knotless suture anchor consisting of an eyelet and a hollow anchor body; pre-mounted on a driver with components separated on the shaft. Used by orthopedic surgeons in clinical settings for soft tissue-to-bone fixation. Device secures suture to bone, facilitating tissue repair; benefits include simplified knotless fixation. FiberWire suture may be provided. Operation involves manual insertion into bone via the driver; mechanical fixation achieved through anchor design.

Clinical Evidence

No clinical data. Evidence consists of bench testing (mechanical pull-out/tensile, insertion) and animal studies (histology, in-vivo pull-out, and in-vivo imaging) demonstrating substantial equivalence to predicate devices.

Technological Characteristics

Two-component knotless suture anchor (eyelet and hollow body). Materials: Bio, BioComposite, PEEK, and Titanium. Delivered via pre-mounted driver. Mechanical fixation principle.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip orthopedic procedures, including ligament and tendon repairs, reconstructions, and tenodesis.

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 BioComposite Suture Anchors (K082810)
• Arthrex PushLock, Tak and Corkscrew Suture Anchors (K061863)
• Arthrex Tenodesis Family (K051726)

Submission Summary (Full Text)

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K101823(1/2)

:

## 3 510(k) Summary of Safety and Effectiveness

| Date Summary Prepared | January 6, 2011 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Sally Foust, RAC<br>Regulatory Affairs Project Manager<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1251<br>Fax: [phone]<br>Email: [e-mail]<br><br>Courtney Smith<br>Regulatory Affairs Project Manager<br>Telephone: [phone], ext. 1720<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | SwiveLock Anchors |
| Common Name | Suture Anchor |
| Product Code -Classification | HWC, MAI |
| Name<br>CFR | 21 CFR 888.3040: Smooth or threaded metallic bone<br>fixation fastener.<br>21 CFR 888.3030: Single/multiple component metallic<br>bone fixation appliances and accessories. |
| Predicate Device | K082810: Arthrex BioComposite Suture Anchors<br>K061863: Arthrex PushLock, Tak and Corkscrew Suture<br>Anchors<br>K051726: Arthrex Tenodesis Family |
| Device Description and Intended<br>Use | The SwiveLock Anchor is a two-component, knotless<br>suture anchor comprised of an eyelet and a hollow anchor<br>body. The SwiveLock Anchor is pre-mounted on a driver<br>with the anchor body and eyelet physically separated on<br>the driver shaft. FiberWire suture may also be provided<br>with the device.<br><br>The Arthrex SwiveLock Anchor is intended for fixation of<br>suture (soft tissue) to bone in the shoulder, foot/ankle |

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K101823(\$^{2}/_{2}\$)

| | procedures. Refer to the Indications For Use Form for<br>specific indications for use. | JAN - 7 2011 | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|
| Substantial Equivalence<br>Summary | The Arthrex SwiveLock Anchors are substantially<br>equivalent to the Arthrex BioComposite Suture<br>Anchors, Arthrex PushLock, Tak and Corkscrew<br>Suture Anchors, and Arthrex Tenodesis Family<br>predicates, in which the basic features and intended uses<br>are the same. Any differences between the SwiveLock<br>Anchors and the predicates are considered minor and do<br>not raise questions concerning safety and effectiveness. | | |
| | The proposed devices are composed of Bio,<br>BioComposite, Peek, and Titanium materials that are<br>substantially equivalent to the predicate devices. | | |
| | The submitted 26-week degradation data, mechanical pull-<br>out (tensile) testing data, insertion testing data, animal<br>testing (including histology, in-vivo pull-out and in-vivo<br>imaging) data demonstrated that the proposed devices are<br>substantially equivalent to the pull-out forces of the<br>predicate devices and that there are no new issues of safety<br>and effectiveness. | | |
| | Based on the indication for use, technological<br>characteristics, degradation testing, mechanical pull-out<br>testing, insertion testing, animal testing (including<br>histology, in-vivo pull-out and in-vivo imaging) and design<br>comparison to the predicate devices, Arthrex, Inc. has<br>determined that the SwiveLock Anchors are substantially<br>equivalent to currently marketed predicate devices. | | |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three horizontal lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

Arthrex, Inc. % Ms. Sally Foust Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

JAN - 7 2017

Re: K101823

Trade/Device Name: Arthrex Swivelock Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: January 5, 2011 Received: January 6, 2011

Dear Ms. Foust:

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 indicions 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 Amendmants, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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, incring of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

and the contract of the country of the country of the county of

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Page 2 - Ms. Sally Foust

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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N Melkerson
Director
Division of Surgical, Orthopedic,
and Restorative Devices

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## dications for Use Form

## Indications for Use

| 510(k) Number (if known): | K101823 | JAN - 7 2011 |
|---------------------------|---------------------------|--------------|
| Device Name: | Arthrex SwiveLock Anchors | |
| Indications For 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 Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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 |

Prescription Use _ V _ AND/OR Over-The-Counter Use _____ (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 of 1

for M. Meikerson

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K100823

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