Tyber Medical BioTy® Nanotopography Trauma Screw

K161597 · Tyber Medical, LLC · HWC · Nov 16, 2016 · Orthopedic

Device Facts

• Record ID: K161597
• Device Name: Tyber Medical BioTy® Nanotopography Trauma Screw
• Applicant: Tyber Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Nov 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A trauma screw with BioTy® Nanotopography Surface Treatment is designed to apply compression and fixation between two adjacent segments of cortical and/or cancellous bone.

Device Story

Trauma screw designed for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fixation; applies compression and fixation between cortical and/or cancellous bone segments. Device features BioTy® Nanotopography surface treatment. Used by surgeons in clinical/OR settings for orthopedic procedures. Benefits include mechanical stabilization of bone segments to facilitate healing. Single-use implant.

Clinical Evidence

No clinical data provided. Nonclinical evidence includes engineering analysis of surface treatment and pyrogenicity testing per ST72:2011. Mechanical strength testing was not repeated as the device is identical to previously cleared devices.

Technological Characteristics

Metallic bone fixation fastener; features BioTy® Nanotopography surface treatment. Materials have established history in orthopedic implants. Pyrogenicity testing performed per ST72:2011.

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. Intended for 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.

Submission Summary (Full Text)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image 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

November 16, 2016

Tyber Medical LLC Mark Schenk Vice President Of Regulatory And Quality 89 Headquarters Plaza North, #1464 Morristown. New Jersey 07960

Re: K161597

Trade/Device Name: Tyber Medical BioTy® Nanotopography 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: October 26, 2016 Received: October 31, 2016

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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" (21 CFR 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

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

### Indications for Use

510(k) Number (if known) K161597

Device Name

Tyber Medical BioTy® Nanotopography Trauma Screw

Indications for Use (Describe)

The Tyber Medical BioTy® Nanotopography Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screw is 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)

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Form Approved: OMB No. 0910-0120

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### Traditional 510(k) Summary

as required by section 807.92(c).

# Tyber Medical

## BioTy® Nanotopography Trauma Screw

### K161597

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| Intended Use | A trauma screw with BioTy® Nanotopography Surface Treatment is<br>designed to apply compression and fixation between two adjacent<br>segments of cortical and/or cancellous bone. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Tyber Medical BioTy® Nanotopography Trauma Screw is<br>indicated for use in bone reconstruction, osteotomy, arthrodesis,<br>joint fusion, fracture repair, and fracture fixation of bones<br>appropriate for the size of the device. The screw is intended for<br>single use only. |

| Statement of | Tyber Medical BioTy® Nanotopography Trauma Screw and its |
|------------------------|--------------------------------------------------------------------|
| Technological | predicate device have the same as or similar indications for use, |
| Comparison and | design, materials, technology and principles of operation and test |
| Fundamental Scientific | results. |
| Technology | |

| Nonclinical Testing<br>Summary | No new mechanical testing in regards to the strength of the implant<br>was performed for this submission because the devices are identical<br>to previously cleared devices.<br><br>The purpose of this submission is to add detail to the description of<br>the modified surface treatment. Additional invitro testing and<br>engineering analysis of the surface treatment was performed.<br><br>Pyrogenicity testing was performed per ST72:2011. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | n/a |

| Conclusion | The Tyber Medical BioTy® Nanotopography Trauma Screw and its predicate device have the same indications for use, and the same design, and test results. Both devices are manufactured using materials with a long history of use in orthopedic implants. |
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