Arrowhead Mini-Rail Fixator

K162032 · Arrowhead De, LLC · KTT · Feb 21, 2017 · Orthopedic

Device Facts

• Record ID: K162032
• Device Name: Arrowhead Mini-Rail Fixator
• Applicant: Arrowhead De, LLC
• Product Code: KTT · Orthopedic
• Decision Date: Feb 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arrowhead Mini-Rail Fixator is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.

Device Story

Unilateral external fixator system for bone stabilization, lengthening, and deformity correction. Device consists of a fixation rail and clamps; clamps move linearly along the rail to apply compression or distraction forces. Accommodates fixation screws (1.6mm to 3.0mm diameter). Used by orthopedic surgeons in clinical settings. Fixation screws are stainless steel (optionally hydroxyapatite-coated); rail/clamps are aluminum and stainless steel. Provides stable mechanical support for bone healing; allows independent clamp positioning for multi-site force application.

Clinical Evidence

Bench testing only. Finite Element Analysis (FEA) performed in accordance with ASTM F1541-02 demonstrated that the device components met performance requirements and are equivalent in strength and stiffness to the predicate device.

Technological Characteristics

Materials: Aluminum and stainless steel (rail/clamps), stainless steel (screws, with/without hydroxyapatite coating). Design: Unilateral rail system with adjustable fixation clamps for linear translation, compression, and distraction. Dimensions: Accommodates 1.6mm to 3.0mm diameter screws. Sterilization: Fixation screws provided sterile; non-implantable components provided non-sterile. Testing: ASTM F1541-02.

Indications for Use

Indicated for patients requiring stabilization of fractures (open, comminuted), infected non-unions, bone length discrepancies, fusions, or corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.

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

• SIDEKICK Rail Fixator (K080071)
• Apex Kirschner Wires and Steinmann Pins (K121004)
• ST.A.R.90 F4 External Fixation Screws With Hydroxyapatite (K150661)

Submission Summary (Full Text)

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

February 21, 2017

Arrowhead DE, LLC Thomas Twardzik VP-Marketing and Operations 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017

Re: K162032 Trade/Device Name: Arrowhead Mini-Rail Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, JDW, HTY Dated: January 18, 2017 Received: January 23, 2017

Dear Thomas Twardzik:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Vincent J. Devlin -S

for

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

Enclosure

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### Indications for Use

510(k) Number (if known) K162032

Device Name Arrowhead Mini-Rail Fixator

Indications for Use (Describe)

The Arrowhead Mini-Rail Fixator is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metarsal, ulnar, and calcaneal bones.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Section 1: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for the Arrowhead Mini-Rail Fixator 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

| Sponsor: | Arrowhead Medical Device Technologies, LLC<br>328 Poplar View Lane East, Suite 2<br>Collierville, TN 38017 | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas J. Twardzik<br>Vice President, Marketing and Operations<br>Office: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date of<br>Submission: | July 20, 2016 | |
| Proprietary<br>Name: | Arrowhead Mini-Rail Fixator | |
| Common Name | External Fixator and fixations screws | |
| Regulatory Class | Class II | |
| Regulation | 21 CFR 888.3030 | Single/multiple component metallic bone fixation appliances and accessories |
| | 21 CFR 888.3040 | Smooth or threaded metallic bone fixation fastener |
| Device Product<br>Code and Panel | KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Single/multiple component metallic bone fixation appliances and accessories. |
| | HTY | Pin, Fixation, Smooth - Smooth or threaded metallic bone fixation fastener. |
| | JDW | Pin, Fixation, Threaded - Smooth or threaded metallic bone fixation fastener. |
| | Orthopedic | |

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| Predicate<br>Devices | SIDEKICK Rail Fixator<br>Apex Kirschner Wires and Steinmann Pins<br>ST.A.R.90 F4 External Fixation Screws<br>With Hydroxyapatite | K080071<br>K121004<br>K150661 |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Device<br>Description | The Arrowhead Mini-Rail Fixator is a unilateral fixator that provides a<br>stable solution for fractures, for lengthening of bones and for correcting<br>deformities. | |
| | The Fixation Clamps are capable of controlled linear translation along the rail and of applying either compression or distraction forces. Because the Fixation Clamps can move along the rail independently of one another, a distraction force can be applied at one location along the Fixation Rail and distraction forces applied at another location along the same Fixation Rail.<br>The Fixation Clamps are capable of securing Fixation Screws with a diameter of 1.6mm to 3.0mm. The rail system and clamps are manufactured from aluminum and stainless steel. The fixation screws are stainless steel and available with and without hydroxyapatite coating.<br>The fixation screws are provided sterile while the non-implantable fixator components are provided non-sterile. | |
| Intended Use | The Arrowhead Mini-Rail Fixator is indicated for stabilizing various<br>fractures including open and comminuted fractures, infected non-unions,<br>fractures with length discrepancies, fusions and corrective osteotomies of<br>the metacarpal, metatarsal, ulnar, and calcaneal bones. | |
| Performance<br>Data | The Arrowhead Mini-Rail Fixator was evaluated using Finite Element<br>Analysis (FEA) in accordance with ASTM F1541-02. The FEA testing<br>demonstrated that The Arrowhead Mini-Rail Fixator components met<br>performance requirements and are equivalent in strength and stiffness to<br>the predicate device. | |
| Technological<br>Characteristics<br>and Substantial<br>Equivalence | The Arrowhead Mini-Rail Fixator is technologically substantially<br>equivalent to predicate devices in terms of intended use, material, design,<br>mechanical performance and safety. The design characteristics of the<br>subject system do not raise any new types of questions of safety or<br>effectiveness. From the evidence submitted in this 510(k), the subject<br>devices can be expected to perform at least as well as the predicate device. | |