ARTHREX SCAPHOLUNATE ANCHOR

K111661 · Arthrex, Inc. · MBI · Aug 19, 2011 · Orthopedic

Device Facts

• Record ID: K111661
• Device Name: ARTHREX SCAPHOLUNATE ANCHOR
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Graft-Anchor 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: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate 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, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) 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

Graft-Anchor is a one-piece titanium push-in bone fixation anchor; pre-loaded on a driver. Used by surgeons in clinical settings (OR) for soft tissue-to-bone fixation across multiple orthopedic sites (shoulder, knee, elbow, hand/wrist, foot/ankle). Device functions by providing mechanical anchor point for sutures to secure tissue or grafts. Surgeon inserts anchor into bone; provides fixation strength for tendon/ligament repairs. Benefits include secure tissue reattachment to bone, facilitating healing in orthopedic reconstructions.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated that the pull-out strength of the device meets or exceeds the predicate device.

Technological Characteristics

One-piece titanium push-in bone fixation anchor. Pre-loaded on a driver. Metallic bone fixation fastener per 21 CFR 888.3040.

Indications for Use

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

• Arthrex Mini PushLock (K063479)

Submission Summary (Full Text)

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AUG 1 9 2011

Arthrex SPECIAL 510(k): Arthrex Scapholunate Anchor

## 2 510(k) Summary of Safety and Effectiveness

| Date Summary Prepared | June 9, 2011 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor<br>/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Courtney Smith<br>Manager, Regulatory Affairs<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 | Graft-Anchor |
| Common Name | Screw, Fixation, Bone |
| Product Code -<br>Classification Name | HWC – Screw, fixation, bone<br>MBI – Fastener, fixation, nondegradable, soft tissue<br>21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories.<br>21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Predicate Devices | K063479: Arthrex Mini PushLock |
| Device Description and<br>Intended Use | The Arthrex Graft-Anchor is a one-piece titanium “push-in” anchor and comes pre-loaded on a driver.<br>The Arthrex Graft-Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. |
| Substantial Equivalence<br>Summary | The Arthrex Graft-Anchor is substantially equivalent to the Arthrex Mini PushLock predicate, in which the basic features, and intended uses are the same. Any differences between the Graft-Anchor and the predicate are considered minor and do not raise questions concerning safety and effectiveness.<br>The mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate device. Based on the indication for use, technological characteristics, and the comparison to the predicate device, Arthrex, Inc. has determined that the Arthrex Graft-Anchor is substantially equivalent to currently marketed predicate device. |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the top and then separate into three distinct shapes at the bottom.

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

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

AUG 1 9 2011

Re: K111661

Trade/Device Name: Arthrex Graft-Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: August 3, 2011 Received: August 4, 2011

Dear Ms. 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, 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 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

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Page 2 - Ms. Courtney Smith

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/AboutfiDA/CentersOffices/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/ReportalProblem/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,

E. M. Keith

- So 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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## 1 Indications for Use Form

## Indications for Use

510(k) Number:

Device Name:

K11661 Arthrex Graft-Anchor

Indications For Use:

## Indications for Use:

The Arthrex Graft-Anchor 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:

| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>Reconstruction |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Repair/Reconstruction of<br>collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP,<br>DIP and MCP joints for all digits, digital tendon transfers, Carpal<br>Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal<br>thumb joint arthroplasty) |
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,<br>Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital<br>tendon transfers, Mid-foot reconstruction |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,<br>Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial<br>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)

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for M. Malkerson
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111661