BIOBOLT

K120540 · Arthrex, Inc. · MAI · Mar 20, 2012 · Orthopedic

Device Facts

• Record ID: K120540
• Device Name: BIOBOLT
• Applicant: Arthrex, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Mar 20, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Arthrex BioComposite GraftBolt is a bone fixation device consisting of a pre-packaged mating sheath and screw pair. Used in orthopedic surgery for cruciate ligament reconstruction; facilitates fixation of ligament, tendon, or bone-tendon-bone grafts to bone. Operated by orthopedic surgeons in clinical/OR settings. Device provides mechanical fixation of graft tissue to bone. Benefits include secure graft attachment during healing. Material composition is biocomposite, consistent with previously cleared Arthrex devices.

Clinical Evidence

Bench testing only. Degradation and biomechanical testing were performed to demonstrate that the ultimate load strength of the device meets or exceeds minimum acceptance criteria.

Technological Characteristics

Bone fixation screw and mating sheath system. Constructed from biocomposite material identical to predicate devices (K112040, K071177). Mechanical fixation principle. Offered in various sizes.

Indications for Use

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

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 Tibial GraftBolt (K093912, K103060)
• Arthrex BioComposite Transfix (K112040)
• Arthrex BioComposite Interference Screws (K071177)

Submission Summary (Full Text)

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K 12.0540 (1/2)

Special 510(k): Arthrex BioComposite GraftBolt, February 17, 2012

MAR 2 0 2012

Arthrex SPECIAL 510(K); ARTHREX BIOCOMPOSITE GRAFTBOLT

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

| Date Summary Prepared | February 15, 2012 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/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 | Arthrex BioComposite GraftBolt |
| Common Name | Screw, Fixation, Bone |
| Product Code -Classification<br>Name | HWC - Screw, fixation, bone<br>MAI - Fastener, fixation, biodegradable |
| CFR | 21 CFR 888.3030: Single/multiple component metallic bone<br>fixation appliances & accessories |
| Predicate Device | K093912, K103060: Arthrex Tibial GraftBolt<br>K112040: Arthrex BioComposite Transfix<br>K071177: Arthrex BioComposite Interference Screws |
| Purpose of Submission | This special 510(k) premarket notification is submitted to<br>obtain clearance for the BioComposite GraftBolt, which is a<br>line-extension of the Arthrex Tibial GraftBolt (K093912,<br>K103060). |
| Device Description and Intended<br>Use | The Arthrex BioComposite GraftBolt consists of a pre-<br>packaged mating sheath and a screw pair offered in various<br>sizes.<br><br>The Arthrex BioComposite GraftBolt is intended to be used<br>for fixation of tissue including ligament or tendon to bone and<br>bone tendon bone during cruciate ligament reconstruction<br>procedures. |
| Substantial Equivalence<br>Summary | The Arthrex BioComposite GraftBolt is substantially<br>equivalent to the Arthrex Tibial GraftBolt (K093912,<br>K103060) in which the basic features, and intended uses are<br>the same. The biocomposite material is the same material<br>used in the Arthrex BioComposite Transfix (K112040) and |
| BioComposite Interference Screws (K071177). | Any differences between the <i>BioComposite GraftBolt</i> and<br>the predicate devices are considered minor and do not raise<br>questions concerning safety and effectiveness.<br><br>The submitted degradation and biomechanical testing data<br>demonstrates that the ultimate load strength of the proposed<br>devices meets or exceeds the minimum acceptance criteria.<br><br>Based on the indication for use, technological characteristics<br>and the comparison to the predicate devices, Arthrex, Inc. ha<br>determined that the <i>Arthrex BioComposite GraftBolt</i> is<br>substantially equivalent to currently marketed predicate<br>devices. |

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Special 510(k): Arthrex BioComposite GraftBolt, February 17, 2012

Arthrait SPECIAL 510(K): ARTHREX BIOCOMPOSITE GRAFTBOLT .

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

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

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

MAR 2 0 2012

Re: K120540

Trade/Device Name: Arthrex BioComposite GraftBolt Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: MAI, HWC Dated: March 6, 2012 Received: March 8, 2012

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 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/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,

for At. B. A.

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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Special 510(k): Arthrex BioComposite GraftBolt, February 17, 2012

Arthrex SPECIAL 510(K): ARTHREX BIOCOMPOSITE GRAFTBOLT

# Indications for Use Form

## Indications for Use

510(k) Number:

1

Device Name:

Arthrex BioComposite GraftBolt

Indications For Use:

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

AND/OR Over-The-Counter Use Prescription Use V (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

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

10 of 241

K 120540(11)