ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS

K091844 · Arthrex, Inc. · MAI · Aug 28, 2009 · Orthopedic

Device Facts

• Record ID: K091844
• Device Name: ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS
• Applicant: Arthrex, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Aug 28, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Bio-Composite SutureTak Anchors family is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Please see indications for use form for specific indications.

Device Story

Arthrex Bio-Composite SutureTak Anchors are orthopedic fixation devices used for soft tissue-to-bone attachment. The device consists of a suture anchor made from a bio-composite material (PLLA or PLDLA combined with TCP). It is used by orthopedic surgeons in clinical settings (OR) to secure sutures or tissues during reconstructive procedures in the foot, ankle, knee, hand, wrist, elbow, and shoulder. The anchor is implanted into bone to provide a secure point for suture attachment, facilitating tissue healing and stabilization. The bio-composite material is designed to be compatible with the surgical site. The device is provided to surgeons to address specific patient needs based on the size of the anchor required for the anatomical site.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarity to the predicate device.

Technological Characteristics

Materials: Bio-composite (PLLA or PLDLA combined with TCP). Form factor: Suture anchor, including smaller models. Function: Soft tissue-to-bone fixation. Sterilization: Not specified.

Indications for Use

Indicated for suture or tissue fixation in foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific applications include: Elbow (Biceps tendon reattachment, collateral ligament reconstruction); Shoulder (Rotator cuff, Bankart, SLAP lesion, biceps tenodesis, AC separation, deltoid, capsular shift/reconstruction); Hand/Wrist (Scapholunate/carpal ligament reconstruction, collateral ligament repair, flexor/extensor tendon repair at PIP/DIP/MCP joints, digital tendon transfers); Foot/Ankle (Lateral/medial stabilization, Achilles tendon repair, metatarsal ligament repair, Hallux Valgus reconstruction, digital tendon transfers, mid-foot reconstruction); Knee (MCL/LCL/patellar tendon/posterior oblique ligament repair, iliotibial band 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 Bio-Composite Suture Anchors (K071177)

Submission Summary (Full Text)

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K0918YY

AUG 2 8 2009

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

| Manufacturer/Sponsor | Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Ivette Galmez<br>Regulatory Affairs Associate<br>Telephone: [phone], ext. 1263<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Bio-Composite SutureTak Anchors |
| Common Name | Suture Anchor |
| Product Code -<br>Classification Name | MAI - Fastener, Fixation, Biodegradable, Soft Tissue<br>HWC - Screw, Fixation, Bone |
| Predicate Device(s) | Arthrex Bio-Composite Suture Anchors: K071177 |
| Device Description<br>and Intended Use | The Arthrex Bio-Composite SutureTak Anchors family<br>is similar to the predicate devices in overall design. The<br>difference lies in the introduction of smaller SutureTak models<br>made with Bio-Composite material (PLLA or PLDLA combined<br>with TCP).<br><br>The Arthrex Bio-Composite SutureTak Anchors family is intended<br>to be used for suture or tissue fixation in the foot, ankle, knee, hand,<br>wrist, elbow, and shoulder. Please see indications for use form for<br>specific indications. |
| Substantial<br>Equivalence Summary | The Arthrex Bio-Composite SutureTak Anchors family is<br>substantially equivalent to the Arthrex Bio-Composite Suture Anchors<br>predicate, in which the basic features and intended uses are the<br>same. Any differences between the Bio-Composite SutureTak<br>Anchors and the predicate K071177 are considered minor and do not<br>raise questions concerning safety and effectiveness. Based on the<br>information submitted, Arthrex, Inc. has determined that the new Bio-<br>Composite SutureTak Anchors family is substantially equivalent to<br>currently marketed predicate devices. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

## AUG 2 8 2009

Arthrex, Inc. c/o Ms. Ivette Galmez Regulatory Affairs Associate 1370 Creekside Blvd. Naples, Florida 34108-1945

Re: K091844

> Trade/Device Name: Arthrex Bio-Composite SutureTak Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: July 29, 2009 Received: July 30, 2009

Dear Ms. Galmez:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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## Page 2 - Ms. Ivette Galmez

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/ucm115809.htm 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,

Barbara Buchner

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

Enclosure

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Indications for Use

510(k) Number: Device Name:

691844

Device Name:

Arthrex Bio-Composite Tak

The Arthrex Bio-Composite Tak 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. |

Prescription Use X AND/OR Over-The-Counter Use J

(21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE) PAGE 1 of 1

Souetu for mcm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091844