ARTHREX BIOCOMPOSITE SUTURETAK

K110660 · Arthrex, Inc. · MAI · Mar 31, 2011 · Orthopedic

Device Facts

• Record ID: K110660
• Device Name: ARTHREX BIOCOMPOSITE SUTURETAK
• Applicant: Arthrex, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Mar 31, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex BioComposite SutureTak 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 and are size appropriate per patient needs: 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 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. 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

2.0mm biocomposite suture anchor; molded-in eyelet; pre-loaded with polyester suture on driver. Used by orthopedic surgeons in clinical settings for soft tissue-to-bone fixation. Device provides mechanical anchor for sutures to reattach tendons or ligaments to bone. Benefits include secure tissue fixation during healing. Mechanical performance verified via ultimate load strength testing after 16 weeks of degradation.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated that ultimate load strength of the device after 16 weeks of degradation meets or exceeds minimum acceptance criteria.

Technological Characteristics

2.0mm biocomposite suture anchor; molded-in suture eyelet; pre-loaded with polyester suture; delivered via driver. Mechanical fixation device.

Indications for Use

Indicated for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder for patients requiring ligament, tendon, or capsular repair/reconstruction.

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 SutureTak Anchors (K091844)

Submission Summary (Full Text)

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K 110660 (1/1)

Arthrex SPECIAL 510(k): Arthrex BioComposite SutureTak

MAR 3 1 2011

## 4 510(k) Summary of Safety and Effectiveness

| Date Summary Prepared | March 2, 2011 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor<br>/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Courtney Smith<br>Regulatory Affairs Project Manager<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1720<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex BioComposite SutureTak |
| Common Name | Suture Anchor |
| Product Code - | HWC - Screw, fixation, bone |
| Classification Name | MAI - Fastener, fixation, biodegradable, soft tissue |
| Predicate Devices | K091844: Arthrex BioComposite SutureTak Anchors |
| Device Description and<br>Intended Use | The Arthrex BioComposite SutureTak is a 2.0mm biocomposite<br>suture anchor with a molded-in suture eyelet. The anchor is<br>loaded on a driver and pre-loaded polyester suture.<br><br>The Arthrex BioComposite SutureTak family is intended to be<br>used for suture or tissue fixation in the foot, ankle, knee, hand,<br>wrist, shoulder, and elbow. Please see indications for use form<br>for specific indications. |
| Substantial Equivalence<br>Summary | The Arthrex BioComposite SutureTak is substantially<br>equivalent to the Arthrex BioComposite SutureTak Anchors<br>(K091844), in which the basic features, materials and intended<br>uses are the same. Any differences between the BioComposite<br>SutureTak and the predicate are considered minor and do not<br>raise questions concerning safety and effectiveness.<br><br>The submitted mechanical testing data demonstrated that the<br>ultimate load strength of the proposed devices after 16 weeks of<br>degradation meets or exceeds the minimum acceptance criteria.<br>Based on the indication for use, technological characteristics, and<br>the comparison to the predicate devices, Arthrex, Inc. has<br>determined that the Arthrex BioComposite SutureTak is<br>substantially equivalent to currently marketed predicate devices. |

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

Arthrex, Inc. % Courtney Smith Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

MAR 3 1 2911

Re: K110660

Trade/Device Name: Arthrex BioComposite SutureTak Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: March 02, 2011 Received: March 09, 2011

Dear Courtney 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. Ilsting 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.

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Page 2 - Courtney Smith

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm111800.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 vours.

Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Arthreach SPECIAL 510(k): Arthrex BioComposite SutureTak

## 3 Indications for Use Form

Indications for Use

510(k) Number:

K110660 (1/1)

Device Name:

Arthrex BioComposite SutureTak

Indications For Use:

The Arthrex BioComposite SutureTak 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 and are size appropriate per patient needs:

| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shoulder: | Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis,<br>Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction,<br>Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor<br>Tendons at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers. |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal<br>Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot<br>reconstruction. |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar<br>Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. |

Prescription Use _ X_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 I of 1

for m. melkerson

(Division Sign-Off) (Division Surgical, Orthopedic, and Restorative Devices

510(k) Number K110660