ARTHREX TIBIAL GRAFTBOLT

K093912 · Arthrex, Inc. · MBI · Mar 18, 2010 · Orthopedic

Device Facts

• Record ID: K093912
• Device Name: ARTHREX TIBIAL GRAFTBOLT
• Applicant: Arthrex, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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

Arthrex Tibial GraftBolt is a bone fixation fastener consisting of a pre-packaged mating sheath and screw pair. Used by orthopedic surgeons in clinical settings during cruciate ligament reconstruction procedures. Device provides mechanical fixation of soft tissue (ligament/tendon) or bone-tendon grafts to bone. Operates via threaded engagement to secure graft within bone tunnel. Benefits include stable graft fixation to facilitate healing and joint stability post-reconstruction.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparison to predicate devices.

Technological Characteristics

Metallic bone fixation fastener consisting of a mating sheath and screw pair. Offered in three sizes. Designed for use in orthopedic bone fixation (Product Code MBI).

Indications for Use

Indicated for fixation of ligament or tendon to bone and bone-tendon during cruciate ligament reconstruction procedures in patients requiring such orthopedic surgical intervention.

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

• Bio-Intrafix™ Tibial Screw and Sheath (K032167)
• AperFix® Tibial Implant with Inserter (K083607)

Submission Summary (Full Text)

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Arthrex TRADITIONAL 510(k): Arthrex Tibial GraftBott

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

| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | David D'Alessandro<br>Quality Engineer<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1117<br>Fax: [phone]<br>Email: david.d'[e-mail] |
| Trade Name | Arthrex Tibial GraftBolt |
| Common Name | Screw, Fixation, Bone |
| Product Code- | MBI |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Regulation No. | 888.3040 |
| Predicate Devices | K032167: Bio-Intrafix™ Tibial Screw and Sheath - Mitek Worldwide<br>K083607: AperFix® Tibial Implant with Inserter -- Cayenne Medical |
| Device Description<br>and Intended Use | The Arthrex Tibial GraftBolt consists of a pre-packaged mating<br>sheath and screw pair offered in three sizes. The Arthrex Tibial<br>GraftBolt is intended to be used for fixation of tissue including<br>ligament or tendon to bone and bone tendon during cruciate ligament<br>reconstruction procedures. |
| Substantial<br>Equivalence<br>Summary | The Arthrex Tibial GraftBolt is substantially equivalent to the<br>predicate devices in which the basic features and intended uses are<br>very similar. Any differences between the Arthrex Tibial GraftBolt<br>and the predicate devices are considered minor and do not raise<br>questions concerning safety and effectiveness.<br>Based on the<br>information submitted, Arthrex, Inc. has determined that the Arthrex<br>Tibial GraftBolt is substantially equivalent to the currently marketed<br>predicate devices similar |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircles the eagle. The seal is in black and white and has a simple, official design.

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

Arthrex, Inc. % Mr. David D'Alessandro Quality Assurance Engineer 1370 Creekside Boulevard Naples, Florida 34108

MAR 1 8 2010

Re: K093912

Trade/Device Name: Arthrex Tibial GraftBolt Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: December 17, 2009 Received: December 22, 2009

Dear Mr. D'Alessandro:

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 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 - Mr. David D'Alessandro

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/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 Buehn

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 TRADITIONAL 510(k): Arthrex Tibial GraftBot1

## 2 Indications for Use Form

510(k) Number:

K093912

Device Name:

Arthrex Tibial GraftBolt

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

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Souther for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093912