TYBER MEDICAL TRAUMA SCREW

K133842 · Tyber Medical, LLC · HWC · Mar 20, 2014 · Orthopedic

Device Facts

• Record ID: K133842
• Device Name: TYBER MEDICAL TRAUMA SCREW
• Applicant: Tyber Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Mar 20, 2014
• 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. The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

Device Story

Tyber Medical Trauma Screw is a metallic bone fixation fastener used for compression and fixation of bone segments. Available in solid or cannulated configurations, the device is manufactured from titanium or stainless steel. It is intended for use by surgeons in clinical settings for procedures including bone reconstruction, osteotomy, arthrodesis, joint fusion, and fracture repair. The screw is implanted to provide mechanical stability across bone segments, facilitating healing. It is a single-use device.

Clinical Evidence

No clinical data. Bench testing only, consisting of pullout and torsional yield testing per ASTM F564.

Technological Characteristics

Metallic bone fixation fastener; titanium or stainless steel; solid or cannulated form factor; mechanical fixation principle; ASTM F564 testing standards applied.

Indications for Use

Indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation in patients requiring bone fixation appropriate for the device size. Contraindications not specified.

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

• WRIGHT COMPRESSION SCREWS; Wright Medical - K082320
• HEADLESS COMPRESSION SCREW; Synthes - K021556
• VILEX/DUAL CANNULATED BONE SCREW; Vilex - K973309

Submission Summary (Full Text)

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K133842 (pg 1/1) 510(k) Premarket Notification

# 510(k) Summary of Safety and Effectiveness:

### TYBER MEDICAL Interbody System

| Submitter by: | Tyber Medical LLC<br>89 Headquarters Plaza North, #1464<br>Morristown, New Jersey 07960 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jeff Tyber<br>CEO and President<br>Phone: [phone] Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | December 17, 2013 |
| Common Names | Bone Compression Screw |
| Trade Name | Tyber Medical Trauma Screw |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| Product Code | HWC |
| Predicate Devices | 1. WRIGHT COMPRESSION SCREWS; Wright Medical - K082320<br>2. HEADLESS COMPRESSION SCREW; Synthes - K021556<br>3. VILEX/DUAL CANNULATED BONE SCREW; Vilex - K973309 |
| Device Description | General trauma screw for compression and fixation of bone. The sterile and<br>non-sterile implants come solid and cannulated, titanium and stainless steel. |
| Intended Use/<br>Indications for use | A trauma screw designed to apply compression and fixation between two<br>adjacent segments of cortical and/or calcaneus bone.<br>The Tyber Medical Trauma Screws are indicated for use in bone<br>reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and<br>fracture fixation of bones appropriate for the size of the device. Screws are<br>intended for single use only. |
| Performance Data<br>(Non-Clinical and/or<br>Clinical) | Non-clinical mechanical testing was performed consisting of Pullout and<br>Torsional Yield per ASTM F564. All data indicates the device is substantial<br>equivalence to the predicate systems<br>Clinical data and conclusions were not needed for this device. |
| Statement of<br>Technological<br>Comparison | The Tyber Medical Trauma Screw and its predicate devices have the same<br>indications for use; same design; are made of similar materials, same<br>application, and have the same anatomic mechanical properties. |
| Conclusion | The Tyber Medical Trauma Screw is substantially equivalent to its predicate<br>devices. This conclusion is based upon indications for use, materials, design,<br>test data and principles of operation. |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

March 20. 2014

Tyber Medical LLC Mr. Jeff Tyber President and CEO 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960

Re: K133842

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 18, 2013 Received: December 23, 2014

Dear Mr. Tyber:

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 device-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. Jeff Tyber

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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. Wigqins

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

Enclosure

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TYBER MEDICAL Trauma Screw

510(k) Premarket Notification

#### Indications for Use

510(k) Number (if known):

Device Name:

K133842 (pg 1/1)

Indications for Use:

Tyber Medical Trauma Screw

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

Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Orthopedic Devices