OsteoBullet Compression Screw

K160304 · Phalanx Innovations · HWC · Apr 29, 2016 · Orthopedic

Device Facts

• Record ID: K160304
• Device Name: OsteoBullet Compression Screw
• Applicant: Phalanx Innovations
• Product Code: HWC · Orthopedic
• Decision Date: Apr 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoBullet Compression Screw is intended to maintain alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodesis of small bones in the hand and foot.

Device Story

OsteoBullet Compression Screw is a metallic or polymer bone fixation fastener used for small bone procedures in the hand and foot. The device is available in cannulated or non-cannulated configurations, ranging from 3-7 mm in diameter and 16-105 mm in length. It is used by orthopedic surgeons in a clinical or surgical setting to maintain bone alignment and fixation during healing. The system includes manual instrumentation such as drill guides, guide wires, depth gauges, drills, taps, and drivers. The device is provided sterile for single use. By providing mechanical stability to the fracture site, the screw facilitates bone union and patient recovery.

Clinical Evidence

Bench testing only. Performance data included axial pushout and torque to failure testing per ASTM F543-13, and static/dynamic 3-point bending per ASTM F1264-14. Results confirmed the device is at least equivalent to predicate devices.

Technological Characteristics

Materials: Titanium 6AL-4V ELI (ASTM F136) or Zeniva™ ZA-500 PEEK (ASTM F2026). Form factor: Cannulated/non-cannulated screws (3-7mm diameter, 16-105mm length). Mechanical fixation principle. Provided sterile for single use. No software or electronic components.

Indications for Use

Indicated for patients requiring fixation of bone fractures, non-unions, osteotomies, or arthrodesis of small bones in the hand and foot.

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

• Ti6® Internal Fixation System (K060026)
• Inion Freedom Screw™ (K123672)

Reference Devices

• DARCO Headless Compression Screw (K080850)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.

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

April 29, 2016

Phalanx Innovations % Ms. Chervl Wagoner Principal Consultant Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408

Re: K160304

Trade/Device Name: OsteoBullet Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 3, 2016 Received: February 4, 2016

Dear Ms. Wagoner:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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 yours,

## 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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### Indications for Use

510(k) Number (if known) K160304

Device Name OsteoBullet Compression Screw

Indications for Use (Describe)

OsteoBullet Compression Screw is intended to maintain alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodeses of small bones in the hand and foot.

| 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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| Date Prepared | April 26, 2016 |
|----------------|-----------------------------------------------------------------------------------------|
| Manufacturer | Phalanx Innovations |
| Address | 200 Cobb Pkwy N<br>Building 200, Suite 210<br>Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| Contact Person | Daniel Lanois<br>General Manager |
| Address | Phalanx Innovations<br>200 Cobb Pkwy N<br>Building 200, Suite 210<br>Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| email | [e-mail] |

| Trade Name | OsteoBullet Compression Screw |
|---------------------|-----------------------------------------------------|
| Common Name | Bone Screw or Internal Fixation Device (non-spinal) |
| Panel Code | Orthopaedics/87 |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Class | Class II |
| Regulation Number | 21 CFR 888.3040 |
| Product Code | HWC |

| Name of Predicate/Reference<br>Device | 510(k) # | Manufacturer |
|-----------------------------------------------------------------------------------------|----------|---------------------------------------|
| Ti6® Internal Fixation System<br>(cleared as Koby Surgical Internal<br>Fixation System) | K060026 | Integra (cleared under Koby Surgical) |
| Inion Freedom Screw™ | K123672 | Inion Oy |
| DARCO Headless Compression<br>Screw (Reference) | K080850 | Wright Medical Technology, Inc. |

| Description | The OsteoBullet Compression Screw has a wide range of diameters and<br>lengths for use in a variety of fracture treatments. Implants are available<br>as cannulated or non-cannulated and made from Titanium 6AL-4V ELI<br>(ASTM F136) or Zeniva™ ZA-500 PEEK (ASTM F2026) and range in<br>size from Ø3 to 7 mm in diameter and 16 to 105 mm in length. Implants<br>are provided sterile and are for single use only. The system includes<br>instrumentation to aid in delivery of the implants including drill guides,<br>guide wires, depth gauge, manual drills, manual stop drills, taps, and<br>drivers. |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Indications and | OsteoBullet Compression Screw is intended to maintain alignment and |
|-----------------|------------------------------------------------------------------------|
| Intended Use | fixation of bone fractures, non-unions, osteotomies, or arthrodesis of |
| | small bones in the hand and foot. |

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| Technological<br>Characteristics | Documentation was provided to demonstrate that the Subject device<br>poses no new risks when compared to the predicate and reference<br>devices presented in this application. The Subject device is identical to<br>the predicate devices in intended use and similar regarding indications<br>for use, materials, technological characteristics, and labeling. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Performance Data | Axial pushout, torque to failure testing (per ASTM F543-13) confirmed<br>that the Subject device performed as intended and is at least equivalent<br>to the predicate devices. Static 3-point bending and dynamic 3-point<br>bending per ASTM F1264-14 further confirmed the performance and<br>substantial equivalence of the Subject device. |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | |
| | Based on the intended use, indications for use, technological<br>characteristics, materials, performance data, and comparison to<br>predicate devices, the Subject device has been shown to be<br>substantially equivalent to legally marketed predicate devices. |