The CrossRoads Screw System is indicated for fracture repair and fixation, reconstruction and arthrodesis of bones appropriate for the size of the device.

Device Description

The CrossRoads Screw System is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy.

AI/ML Overview

This document is a 510(k) premarket notification for the "CrossRoads Screw System." It does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it pertains to a medical device (screw system) rather than a diagnostic or AI-based device that would typically have performance metrics like sensitivity, specificity, or accuracy.

The document is a submission to the FDA seeking clearance for a bone fixation device, asserting its substantial equivalence to previously cleared predicate devices. The information provided is primarily regulatory and descriptive.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract design of an eagle with three heads, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

January 16, 2015

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

OrthoDiscovery Group LLC (D.B.A. CrossRoads Extremity Systems) Mr.Vernon Hartdegen Senior Vice President of Operations 458 Distribution Parkway Collierville, Tennessee 38017

Re: K143039

Trade/Device Name: CrossRoads Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 21, 2014 Received: October 22, 2014

Dear Mr. Hartdegen:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) K143039

Device Name

CrossRoads Screw System

Indications for Use (Describe)

The CrossRoads Screw System is indicated for fracture repair and fixation, reconstruction and arthrodesis of bones appropriate for the size of the device.

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

∑ Prescription Use (Part 21 CFR 801 Subpart D)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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Section 8 - 510(k) Summary

Date:	21 October 2014
Sponsor:	OrthoDiscovery Group LLC (DBA CrossRoads Extremity Systems)458 Distribution ParkwayCollierville, TN 38017 USAPhone: 901.221.8406
Contact Person:	Vernon Hartdegen, VP of Operations
Trade Name:	CrossRoads Screw System
Common Name:	Screw system
Device Classification:	Class II
Regulation, Name:	888.3040, Smooth or threaded metallic bone fixation fastener
Device Product Code:	HWC
Device Description:	The CrossRoads Screw System is comprised of bone screws havingvarious features in a variety of diameters and lengths to accommodatediffering patient anatomy.
Intended Use:	The CrossRoads Screw System is indicated for fracture repair and fixation,osteotomy, joint fusion, reconstruction and arthrodesis of bonesappropriate for the size of the device.
Materials:	The CrossRoads Screw System implant components are manufacturedtitanium alloy (ASTM F136) and stainless steel (ASTM F138).
Predicate Devices:	Dual-Thread and Lag Screws (Vilex Inc. - K014154)Dart-Fire Small and Charlotte Snap-off Screws (Wright MedicalTechnology - K082320, K100359 and K133713)M3-X Lag Screw (OsteoMed Corp. - K924018)Cannulated Screws and QFX Screw (Smith & Nephew - K090675 andK111994)Herbert™ and Cannulated Screw System (Zimmer, Inc. – K102903 andK112885)
Substantialequivalence	Theoretical analysis of the worst case CrossRoads screws was performedto predict torsional and pullout strengths for the subject and predicatedevices. The results demonstrate the predicted performance of theCrossRoads screws is substantially equivalent to the predicate devices.
TechnologicalCharacteristics:	The CrossRoads Screw System possesses the same technologicalcharacteristics as the predicate devices. These include:• predicted performance,• implant grade materials, and• basic design.Therefore the fundamental scientific technology of the CrossRoads ScrewSystem devices is the same as previously cleared devices.
Conclusion:	The CrossRoads Screw System possesses the same intended use andtechnological characteristics as the predicate devices. Therefore theCrossRoads Screw System is substantially equivalent for its intended use.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.