Tyber Medical Trauma Screw

K153575 · Tyber Medical, LLC · HWC · Feb 26, 2016 · Orthopedic

Device Facts

• Record ID: K153575
• Device Name: Tyber Medical Trauma Screw
• Applicant: Tyber Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Feb 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A trauma screw designed to apply compression and fixation between two adjacent segments of cortical and/or calcaneus bone.

Device Story

The Tyber Medical Trauma Screw is a metallic bone fixation fastener used for compression and fixation of cortical or calcaneus bone. It is intended for use in orthopedic procedures including bone reconstruction, osteotomy, arthrodesis, joint fusion, and fracture repair. The device is available in solid or cannulated forms, with options for headed or snap-off designs, and may include an optional washer. It is manufactured from titanium, with or without a modified surface treatment. The device is provided sterile or non-sterile for single use. It is operated by a surgeon in a clinical or surgical setting to stabilize bone segments, facilitating healing through mechanical fixation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, specifically static torsion testing per ASTM F543, and engineering analysis.

Technological Characteristics

Metallic bone fixation fastener made of titanium. Available in solid or cannulated forms. Features include headed, snap-off, and washer options. Surface treatment is optional. Testing performed per ASTM F543. Sterilization provided.

Indications for Use

Indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device size. Single use only.

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

• Tyber Medical Trauma Screw (K133842)

Reference Devices

• Tyber Medical MST Trauma Screw (K153180)

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 26, 2016

Tyber Medical LLC Mark Schenk Director of Quality Assurance and Regulatory Affairs 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960

Re: K153575

Trade/Device Name: Tyber Medical Trauma Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 22, 2015 Received: December 29, 2015

Dear Mr. Schenk:

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/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 yours,

Lori A. Wiggins -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) K153575

Device Name Tyber Medical Trauma Screw

Indications for Use (Describe)

The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Special 510(k) Summary

as required by section 807.92(c).

# Tyber Medical Trauma Screw

### K 153575

| Submitted | 2/25/16 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Tyber Medical LLC |
| | 89 Headquarters Plaza North, #1464 |
| | Morristown, New Jersey 07960 |
| Contact Person | Mark F Schenk |
| | Director of QA/RA |
| | Phone: [phone] Fax: [phone] |
| | Email: [e-mail] |
| Trade Name | Tyber Medical Trauma Screw |
| Common Name | Bone Compression Screw |
| Device Class | Class II |
| Regulation Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 |
| Classification Panel: | Orthopedic |
| Product Code | HWC |
| Predicate Devices | Tyber Medical Trauma Screw – K133842 |
| Reference Device for<br>surface treatment | Tyber Medical MST Trauma Screw – K153180 |
| Device Description | General trauma screw for compression and fixation of bone.<br>This submission adds a headed screw and snap off option as<br>well as an optional washer to the previously cleared headless<br>trauma screw with and without previously cleared modified<br>surface treatment. The screws will be provided sterile and<br>non-sterile in both solid and cannulated form, made of from<br>titanium (with and without Modified Surface treatment) and |
| Intended Use | A trauma screw designed to apply compression and fixation<br>between two adjacent segments of cortical and/or calcaneus<br>bone. |
| Indications for Use | The Tyber Medical Trauma Screw is indicated for use in bone<br>reconstruction, osteotomy, arthrodesis, joint fusion, fracture<br>repair, and fracture fixation of bones appropriate for the size of<br>the device. Screws are intended for single use only. |

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| Statement of<br>Technological<br>Comparison and<br>Fundamental Scientific<br>Technology | Tyber Medical Trauma Screw and its predicate device have<br>the same indications for use, similar design, same materials,<br>technology principles of operation and test results. |
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| Nonclinical Testing Summary | The following tests were performed to demonstrate that the Tyber<br>Medical Trauma Screw is substantially equivalent to the predicate<br>device (K133842).<br><br>Static Torsion Test per ASTM F543 The results of these studies showed that the Tyber Medical Trauma<br>Screw met the acceptance criteria.<br>Additional engineering analysis of the new device and the predicate<br>was also performed to demonstrate substantial equivalence. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | n/a |
| Conclusion | Tyber Medical Trauma Screw and its predicate device have the same indications for use, similar design, and test results. Both devices are manufactured using materials with a long history of use in orthopedic implants. Therefore, the subject device was shown to be substantially equivalent to the predicate device. |