(85 days)
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.
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.
Below is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Axial Pushout Performance (per ASTM F543-13) | Confirmed that the Subject device performed as intended and is at least equivalent to the predicate devices. |
| Torque to Failure (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 (per ASTM F1264-14) | Further confirmed the performance and substantial equivalence of the Subject device. |
| Dynamic 3-point Bending (per ASTM F1264-14) | Further confirmed the performance and substantial equivalence of the Subject device. |
| No new risks compared to predicates | Documentation was provided to demonstrate that the Subject device poses no new risks when compared to the predicate and reference devices. The Subject device is identical to the predicate devices in intended use and similar regarding indications for use, materials, technological characteristics, and labeling. |
2. Sample Size and Data Provenance:
The document does not specify the exact sample sizes (number of screws or tests) used for the performance testing. The data provenance is described as "Documentation was provided" and relates to in vitro mechanical testing of the device itself, rather than human data. There is no mention of country of origin for the data or if it was retrospective or prospective, as these are not relevant for this type of mechanical testing.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable. The study described is not a clinical study involving human patients or expert interpretation of medical data. It is a benchtop (mechanical) performance study comparing a new medical device (OsteoBullet Compression Screw) to existing predicate devices based on objective engineering standards (ASTM F543-13 and ASTM F1264-14). Therefore, there is no "ground truth" to be established by experts in the context of diagnostic accuracy or treatment outcomes.
4. Adjudication Method:
This section is not applicable for the same reasons as point 3. Benchtop mechanical testing does not involve adjudication.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms or imaging devices with human readers. The document describes mechanical performance testing of a physical implant (bone screw).
6. Standalone (Algorithm Only) Performance:
No, a standalone (algorithm only) performance study was not done. The device is a physical bone fixation screw, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this study is defined by established engineering standards and specifications for mechanical performance of bone fixation fasteners (ASTM F543-13 and ASTM F1264-14), and the performance characteristics of the legally marketed predicate devices. The performance metrics (e.g., axial pushout, torque to failure, bending strength) are quantitatively measured according to these standards.
8. Sample Size for the Training Set:
This section is not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How Ground Truth for the Training Set was Established:
This section is not applicable for the same reasons as point 8.
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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 (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
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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 NBuilding 200, Suite 210Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| Contact Person | Daniel LanoisGeneral Manager |
| Address | Phalanx Innovations200 Cobb Pkwy NBuilding 200, Suite 210Marietta, GA 30062 |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| daniel@phalanxinnovations.com |
| 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/ReferenceDevice | 510(k) # | Manufacturer |
|---|---|---|
| Ti6® Internal Fixation System(cleared as Koby Surgical InternalFixation System) | K060026 | Integra (cleared under Koby Surgical) |
| Inion Freedom Screw™ | K123672 | Inion Oy |
| DARCO Headless CompressionScrew (Reference) | K080850 | Wright Medical Technology, Inc. |
| Description | The OsteoBullet Compression Screw has a wide range of diameters andlengths for use in a variety of fracture treatments. Implants are availableas cannulated or non-cannulated and made from Titanium 6AL-4V ELI(ASTM F136) or Zeniva™ ZA-500 PEEK (ASTM F2026) and range insize from Ø3 to 7 mm in diameter and 16 to 105 mm in length. Implantsare provided sterile and are for single use only. The system includesinstrumentation to aid in delivery of the implants including drill guides,guide wires, depth gauge, manual drills, manual stop drills, taps, anddrivers. |
|---|---|
| ------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 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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| TechnologicalCharacteristics | Documentation was provided to demonstrate that the Subject deviceposes no new risks when compared to the predicate and referencedevices presented in this application. The Subject device is identical tothe predicate devices in intended use and similar regarding indicationsfor use, materials, technological characteristics, and labeling. |
|---|---|
| ---------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Performance Data | Axial pushout, torque to failure testing (per ASTM F543-13) confirmedthat the Subject device performed as intended and is at least equivalentto the predicate devices. Static 3-point bending and dynamic 3-pointbending per ASTM F1264-14 further confirmed the performance andsubstantial equivalence of the Subject device. |
|---|---|
| Conclusion | |
| Based on the intended use, indications for use, technologicalcharacteristics, materials, performance data, and comparison topredicate devices, the Subject device has been shown to besubstantially equivalent to legally marketed predicate devices. |
§ 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.