Tyber Medical MST Trauma Screw

K153180 · Tyber Medical, LLC · HWC · Nov 25, 2015 · Orthopedic

Device Facts

• Record ID: K153180
• Device Name: Tyber Medical MST Trauma Screw
• Applicant: Tyber Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Nov 25, 2015
• Decision: SESE
• Submission Type: Special
• 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

Metallic bone fixation fastener; provides compression and fixation between adjacent cortical or calcaneus bone segments. Device consists of solid or cannulated titanium screws with modified surface treatment (MST). Used by orthopedic surgeons in clinical settings for fracture repair and joint fusion. Operates via mechanical fixation; provides structural stability to bone segments during healing. Benefits patient by facilitating bone alignment and stabilization.

Clinical Evidence

No clinical data. Bench testing only: pull-out and static torsion testing per ASTM F543; biocompatibility evaluation per ISO 10993-5; elemental composition verification via X-ray photoelectron spectroscopy (XPS).

Technological Characteristics

Titanium bone fixation screw; solid or cannulated form. Mechanical fixation principle. Surface modified (MST). Testing performed per ASTM F543 (mechanical) and ISO 10993-5 (biocompatibility). Sterile.

Indications for Use

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

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

November 25, 2015

Tyber Medical LLC Mr. Mark F. Schenk Director of QA/RA 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960

Re: K153180

Trade/Device Name: Tyber Medical MST 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: November 3, 2015 Received: November 3, 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 Part 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 [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

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K153180

Device Name

Tyber Medical MST Trauma Screw

Indications for Use (Describe)

The Tyber Medical MST Trauma Screws are 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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

# Special 510(k) Summary

as required by section 807.92(c).

# Tyber Medical MST Trauma Screw

### K 153180

| Updated | 11/23/15 |
|-----------------------|-------------------------------------------------------------|
| 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 MST Trauma Screw |
| Common Name | Bone Compression Screw |
| Device Class | Class II |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| and Number | 21 CFR 888.3040 |
| Classification Panel: | Orthopedic |
| Product Code | HWC |
| Predicate Devices | Tyber Medical Trauma Screw – K133842 |
| Device Description | General trauma screw for compression and fixation of bone |
| | with modified surface treatment (MST). The screws will be |
| | provided sterile in both solid and cannulated form, made of |
| | from titanium. |

{4}------------------------------------------------

| 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 MST Trauma Screws are indicated for use in<br>bone reconstruction, osteotomy, arthrodesis, joint fusion,<br>fracture repair, and fracture fixation of bones appropriate for<br>the size of the device. Screws are intended for single use only. |

| Statement of<br>Technological<br>Comparison and<br>Fundamental Scientific<br>Technology | Tyber Medical MST Trauma Screw and its predicate device<br>have the same indications for use, similar design, similar<br>materials, technology principles of operation and test<br>results. |
|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Nonclinical Testing<br>Summary | The following tests were performed to demonstrate that the<br>Tyber Medical MST Trauma Screw is substantially equivalent to other<br>predicate device. Pull out Test per ASTM F543 Static Torsion Test per ASTM F543 Biocompatibility evaluation including Cytotoxicity testing per<br>ISO 10993-5. X-ray photoelectron spectroscopy (XPS) was performed to<br>verify the MST Trauma Screw have the same elemental<br>composition as the predicate. The results of these studies showed that the Tyber Medical MST<br>Trauma Screw met the acceptance criteria. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | n/a |

| Conclusion | Tyber Medical MST 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. |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|