ARTHREX TIBIAL GRAFTBOLT

K103060 · Arthrex, Inc. · MBI · Jan 5, 2011 · Orthopedic

Device Facts

• Record ID: K103060
• Device Name: ARTHREX TIBIAL GRAFTBOLT
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jan 5, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2

Intended Use

The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures

Device Story

The Arthrex Tibial GraftBolt is a bone fixation device consisting of a mating sheath and screw pair. It is used by surgeons during cruciate ligament reconstruction procedures to secure soft tissue (ligament or tendon) or bone-tendon grafts to bone. The device functions as a mechanical fastener to provide fixation strength. It is intended for use in a clinical/surgical setting.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated that the ultimate load strength of the proposed devices meets or exceeds minimum acceptance criteria.

Technological Characteristics

Bone fixation fastener consisting of a mating sheath and screw pair. Metallic construction. Dimensions extended to include two new sizes. Mechanical fixation principle.

Indications for Use

Indicated for fixation of ligament or tendon to bone and bone-tendon during cruciate ligament reconstruction procedures.

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 Tibial GraftBolt (K093912)

Submission Summary (Full Text)

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Arthrex SPECIAL 510(k): Arthrex GraftBolt

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

| Date Summary Prepared | October 13, 2010 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Tibial GraftBolt |
| Common Name | Screw, Fixation, Bone |
| Product Code -<br>Classification Name | HWC - Screw, fixation, bone |
| Predicate Devices | K093912: Arthrex Tibial GraftBolt |
| Device Description and<br>Intended Use | The Arthrex Tibial GraftBolt consists of a pre-packaged mating<br>sheath and a screw pair offered in two new sizes which extend<br>the current size range.<br>The Arthrex Tibial GraftBolt is intended to be used for fixation<br>of tissue including ligament or tendon to bone and bone tendon<br>during cruciate ligament reconstruction procedures. |
| Substantial Equivalence<br>Summary | The Arthrex Tibial GraftBolt is substantially equivalent to the<br>Arthrex Tibial GraftBolt (K093912), in which the basic features,<br>materials and intended uses are the same. Any differences<br>between the Tibial GraftBolt and the predicate are considered<br>minor and do not raise questions concerning safety and<br>effectiveness.<br>The submitted mechanical testing data demonstrated that the<br>ultimate load strength of the proposed devices meets or exceeds<br>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 Tibial GraftBolt is substantially<br>equivalent to currently marketed predicate devices. |

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized lines representing its body and wings.

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

JAN 5 2011

Arthrex. Inc. c/o Ms. Courtney Smith Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K103060

> Trade/Device Name: Arthrex Tibial GraftBolt Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 19, 2010 Received: December 22, 2010

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. 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 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

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Page 2 - Ms. Courtney Smith

CFR Part 807); labeling (21 CFR Part 801.); 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/CDRHQffices/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,

erely yours,

N. Melkerson

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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Arthrex SPECIAL 510(k): Arthrex GraftBolt

## 3 Indications for Use Form

## Indications for Use

510(k) Number:

KI03060

Device Name:

Arthrex Tibial GraftBolt

Indications For Use:

The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures

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 1 of 1

for M. Melkerson

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

Division of Surgical, of Surgical, of Surgices
and Restorative Devices
and Restorative Devices and Restorative and

K103060

510(k) Number