K Number
K160304
Device Name
OsteoBullet Compression Screw
Date Cleared
2016-04-29

(85 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The OsteoBullet Compression Screw has a wide range of diameters and lengths for use in a variety of fracture treatments. Implants are available as cannulated or non-cannulated and made from Titanium 6AL-4V ELI (ASTM F136) or Zeniva™ ZA-500 PEEK (ASTM F2026) and range in size from Ø3 to 7 mm in diameter and 16 to 105 mm in length. Implants are provided sterile and are for single use only. The system includes instrumentation to aid in delivery of the implants including drill guides, guide wires, depth gauge, manual drills, manual stop drills, taps, and drivers.
More Information

No
The device description and performance studies focus solely on the mechanical properties and physical design of a bone screw and associated instrumentation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.

No.
The device is described as an implantable screw for maintaining alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodeses, which is a structural or mechanical function, not a therapeutic one.

No

The OsteoBullet Compression Screw is an implantable device used for maintaining alignment and fixation of bone fractures and other orthopedic conditions. It is a treatment device, not one that identifies or characterizes a disease or condition.

No

The device description explicitly states it is a physical implant (screw) made of Titanium or PEEK, along with associated surgical instrumentation. This is a hardware medical device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the OsteoBullet Compression Screw is for "maintaining alignment and fixation of bone fractures, non-unions, osteotomies, or arthrodeses of small bones in the hand and foot." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
  • Device Description: The description details a physical implant (screw) and associated surgical instruments.
  • Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.

The information provided describes a surgical implant and its associated tools, which are not considered IVD devices.

N/A

Intended Use / Indications for Use

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.

Product codes

HWC

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

small bones in the hand and foot.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Axial pushout, torque to failure testing (per ASTM F543-13) confirmed that the Subject device performed as intended and is at least equivalent to the predicate devices. Static 3-point bending and dynamic 3-point bending per ASTM F1264-14 further confirmed the performance and substantial equivalence of the Subject device.

Key Metrics

Not Found

Predicate Device(s)

K060026, K123672

Reference Device(s)

K080850

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.

0

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

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

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 PreparedApril 26, 2016
ManufacturerPhalanx Innovations
Address200 Cobb Pkwy N
Building 200, Suite 210
Marietta, GA 30062
Telephone888-404-3980 Ext 101
Fax678-669-2188
Contact PersonDaniel Lanois
General Manager
AddressPhalanx Innovations
200 Cobb Pkwy N
Building 200, Suite 210
Marietta, GA 30062
Telephone888-404-3980 Ext 101
Fax678-669-2188
emaildaniel@phalanxinnovations.com
Trade NameOsteoBullet Compression Screw
Common NameBone Screw or Internal Fixation Device (non-spinal)
Panel CodeOrthopaedics/87
Classification NameSmooth or threaded metallic bone fixation fastener
ClassClass II
Regulation Number21 CFR 888.3040
Product CodeHWC

| Name of Predicate/Reference

Device510(k) #Manufacturer
Ti6® Internal Fixation System
(cleared as Koby Surgical Internal
Fixation System)K060026Integra (cleared under Koby Surgical)
Inion Freedom Screw™K123672Inion Oy
DARCO Headless Compression
Screw (Reference)K080850Wright Medical Technology, Inc.

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

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

4

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

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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