Bicortical Fixation Screw & Washer Nut System

K153638 · First Ray, LLC · HWC · Apr 19, 2016 · Orthopedic

Device Facts

• Record ID: K153638
• Device Name: Bicortical Fixation Screw & Washer Nut System
• Applicant: First Ray, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Apr 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bicortical Fixation Screw & Washer Nut System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

Device Story

Bicortical Fixation Screw & Washer Nut System consists of screws of varying diameters/lengths and a mating washer nut; designed for orthopedic fracture repair, osteotomy, joint fusion, reconstruction, and arthrodesis. Device functions by screw crossing fracture line and engaging washer nut at far cortex to achieve compression of bone fragments. Used by surgeons in clinical settings. Provides mechanical stability to bone segments to facilitate healing. Substantial equivalence established via mechanical testing (torsion and static pullout) compared to predicate screw systems.

Clinical Evidence

Bench testing only. Performance characterized through torsion and static pullout testing in bone analog material. No clinical data required.

Technological Characteristics

Titanium alloy (ASTM F136). Screw and washer nut construct. Designed for bicortical fixation and compression. Mechanical performance validated via torsion and static pullout testing.

Indications for Use

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

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

• Synthes Cortex Screws (K112583)
• CrossRoads Screw System (K152072)

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

April 19, 2016

First Ray LLC Mr. Robert Hov Director of Research 124 South 600 West, Suite 100 Logan, Utah 84321

Re: K153638

Trade/Device Name: Bicortical Fixation Screw & Washer Nut System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: December 17, 2015 Received: December 18, 2015

Dear Mr. Hoy:

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/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

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## Indications for Use

510(k) Number (if known) K153638

Device Name

Bicortical Fixation Screw and Washer Nut System

Indications for Use (Describe)

The Bicortical Fixation Screw & Washer Nut System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

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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## 510(k) Summary

| Device Trade Name: | Bicortical Fixation Screw & Washer Nut System |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | First Ray LLC<br>124 South 600 West, Suite 100<br>Logan, UT 84321 |
| Contact: | Mr. Robert Hoy<br>Director of Research<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | April 14, 2016 |
| Common Name: | Screw, Fixation, Bone<br>Washer, Bolt Nut |
| Classification: | 21 CFR 888.3040, 21 CFR 888.3030 |
| Class: | II |
| Product Codes: | HWC, HTN |

#### Indications for Use:

The Bicortical Fixation Screw & Washer Nut System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

#### Device Description:

The Bicortical Fixation Screw & Washer Nut System consists of screws in various diameters and lengths that mate with a washer nut to achieve bicortical fixation.

### Predicate Devices:

The Synthes Cortex Screws (K112583) and CrossRoads Screw System (K152072) serve as the predicate devices.

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#### Predicate Comparison:

#### Indications

The subject and predicate devices are indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device. There are no differences in the indications between the subject and predicate devices.

#### Technological Characteristics

The subject and predicate devices are manufactured from titanium alloy conforming to ASTM F136. This is a material with a long history of biocompatibility and use in previously cleared permanent implants.

Both the subject and predicate constructs are designed to achieve compression of the fracture fragments. In the case of the Bicortical Fixation Screw & Washer Nut, the screw crosses the fracture line, engages with the Washer Nut at the far cortex, and achieves compression of the fracture. In the case of the predicate device, the screw crosses the fracture line, engages with the far cortex, and achieves compression of the fracture. The mechanical testing demonstrates that this minor difference in technology introduces no new issues of safety or effectiveness.

#### Nonclinical Testing

All necessary testing has been performed for the worst-case Bicortical Fixation Screw & Washer Nut to assure substantial equivalence to its predicates and demonstrate the subject device performs as intended. All testing was performed on test units representative of finished devices.

The device performance was characterized through torsion and static pullout testing in bone analog material. Clinical data are not needed to support the safety and effectiveness of the subject device.

#### Conclusion

Side-by-side performance testing demonstrates the substantial equivalence of the Bicortical Fixation Screw & Washer Nut System to the Synthes Cortex Screws. The Bicortical Fixation Screw & Washer Nut System is substantially equivalent to the Synthes Cortex Screws (K112583) and CrossRoads Screw System (K152072) with respect to its indications for use, material, design, and function.