Arthrex Fracture System

K143139 · Arthrex, Inc. · HRS · Jan 16, 2015 · Orthopedic

Device Facts

• Record ID: K143139
• Device Name: Arthrex Fracture System
• Applicant: Arthrex, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Fracture System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws. The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 FiberWire or FiberTape.

Device Story

Arthrex Fracture System comprises stainless steel plates, screws, and buttons for internal bone fixation. Plates available in various configurations; screws range 2.7mm-4.0mm diameter and 8mm-80mm length; buttons facilitate ligament repair when used with FiberWire/FiberTape. System used by orthopedic surgeons in clinical/surgical settings to stabilize bone segments. This submission introduces sterile packaging options via Gamma Irradiation or Ethylene Oxide sterilization for previously cleared non-sterile components. Device provides mechanical stabilization to promote bone healing.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stainless steel bone fixation plates, screws, and buttons. Screws are solid, fully threaded, locking or non-locking. Sterilization via Gamma Irradiation or Ethylene Oxide.

Indications for Use

Indicated for internal bone fixation of fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. Clavicle plate button indicated for syndesmotic trauma and acromioclavicular separations.

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 Fracture System (K112437)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

January 16, 2015

Arthrex, Inc. David L. Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K143139 Trade/Device Name: Arthrex Fracture System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 15, 2014 Received: December 17, 2014

Dear Mr. Rogers:

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 L. Rogers

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Mark N. Melkerson -S

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

Enclosure

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## 2.5 INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-01 Expiration Date: December 31, 201 See PRA Statement on last page.

510(k) Number (if known)

K143139

Device Name

### Arthrex Fracture System

Indications for Use (Describe)

The Arthrex Fracture System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.0mm Arthrex Low Profile Screws.

The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for the treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 FiberWire or FiberTape.

Type of Use (Select one or both, as applicable)

Ø Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

PSC Publishing Services (301) 443-6

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| 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared | January 15, 2015 |
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | David L Rogers<br>Regulatory Affairs Associate<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 71924<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Fracture System |
| Common Name | Plate, fixation, bone |
| Product Code -Classification Name | HRS - Plate, Fixation, Bone<br>HWC - Screw, Fixation, Bone |
| CFR | 21 CFR 888.3030: Single/multiple component metallic<br>bone fixation appliances and accessories<br>21 CFR 888.3040: Smooth or threaded metallic bone<br>fixation fastener |
| Predicate Device | K112437: Arthrex Fracture System |
| Purpose of Submission | This special 510(k) premarket notification is intended<br>to address the use of Gamma Irradiation and Ethylene<br>Oxide sterilization on the Arthrex Fracture System<br>devices, which were originally cleared as non-sterile<br>devices under K112437. The intended use, material,<br>and fundamental technological characteristics of the<br>proposed Arthrex Fracture System are substantially<br>equivalent to the non-sterile predicates. |
| Device Description | The Arthrex Fracture System is a family of stainless<br>steel plates, screws, and buttons that will be offered<br>as sterile or non-sterile devices. The plates may be<br>contoured or straight and may be available in left and<br>right configurations. The screw family ranges from<br>2.7mm to 4.0mm in diameter and from 8mm to 80mm<br>in length. The screws are solid and fully threaded and<br>may be locking or non-locking. The button is stainless<br>steel and designed to fit securely in the holes of the<br>fracture plates. The button is intended to be used |
| | with the previously cleared suture, which is provided<br>separately. |
| Intended Use | The Arthrex Fracture System is intended to be used for<br>internal bone fixation for bone fractures, fusions,<br>osteotomies, and non-unions in the ankle, foot, hand,<br>wrist, clavicle, scapula, olecranon, humerus, radius,<br>ulna, tibia, calcaneous, femur, and fibula. The Arthrex<br>Fracture Plates are to be used with the 2.7mm-4.0mm<br>Arthrex Low Profile Screws. |
| | The Clavicle Plate Button is intended for use with the<br>clavicle plates for clavicle indications such as for the<br>treatment of syndesmotic trauma, such as fixation of<br>acromioclavicular separations due to coracoclavicular<br>ligament disruption, and this button may not be used<br>alone. The button is intended to be used with #5<br>FiberWire or FiberTape. |
| Substantial Equivalence Summary | The Arthrex Fracture System is substantially<br>equivalent to the predicate devices in which the basic<br>design features and intended uses are the same. Any<br>differences between the Arthrex Fracture System and<br>the predicates are considered minor and do not raise<br>questions concerning safety and effectiveness. |
| | The predicate devices are cleared as non-sterile<br>devices. The proposed devices will undergo Gamma<br>Irradiation or Ethylene Oxide (EO) sterilization. |
| | Based on the indications for use, technological<br>characteristics, and the summary of data submitted,<br>Arthrex, Inc. has determined that the Arthrex Fracture<br>System is substantially equivalent to the predicates. |

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