(58 days)
No
The summary describes a mechanical bone screw system and its performance based on theoretical analysis, with no mention of AI/ML, image processing, or data-driven performance metrics.
No
The device is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis, which are surgical and orthopedic procedures, not therapeutic treatments.
No
Explanation: The device is a screw system used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones. Its purpose is therapeutic/interventional, not diagnostic.
No
The device description explicitly states it is comprised of bone screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on bones (fracture repair, fixation, osteotomy, joint fusion, reconstruction, arthrodesis). This is a therapeutic and structural function, not a diagnostic one performed on samples outside the body.
- Device Description: The description of bone screws further supports its use in surgical intervention, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely different.
N/A
Intended Use / Indications for Use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
Product codes
HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the size of the device.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Theoretical analysis of the worst case CrossRoads screws was performed to predict torsional and pullout strengths for the subject and predicate devices. The Large Screws do not result in a new worst-case within the system. The results demonstrate the predicted performance of the CrossRoads screws is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K143039 CrossRoads Screw System, K000080 and K024060 Stryker Asnis III Screw System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2015
CrossRoads Extremity Systems, LLC % Mr. Vernon Hartdegen Sr. Vice President of Operations 6055 Primacy Parkway Suite 140 Memphis, Tennessee 38119
Re: K152072
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: September 1, 2015 Received: September 3, 2015
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 (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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (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)
Device Name CrossRoads Screw System
Indications for Use (Describe)
The CrossRoads Screw 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date: | July 23, 2015 |
|---|---|
| Device Name: | CrossRoads Screw System |
| Company: | CrossRoads Extremity Systems (previously |
| OrthoDiscovery Group LLC) | |
| 6055 Primacy Parkway, Suite 140 | |
| Memphis, TN 38119 USA | |
| Phone: 901.221.8406 | |
| Primary Contact: | Vernon Hartdegen, Sr. VP of Operations |
| 901.221.8406 | |
| Vhartdegen@crextremity.com | |
| Trade Name: | CrossRoads Screw System |
| Common Name: | Screw System |
| Classification: | Class II |
| Regulation Number: | 888.3040, Smooth or threaded metallic bone fixation |
| fastener | |
| Panel: | Orthopedic |
| Product Code: | HWC |
| Predicate Devices: | K143039 CrossRoads Screw System |
| K000080 and K024060 Stryker Asnis III Screw System | |
| 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. | |
| Indications for Use: | The CrossRoads Screw System is indicated for fracture |
| repair and fixation, osteotomy, joint fusion, reconstruction | |
| and arthrodesis of bones appropriate for the size of the | |
| device. | |
| Materials: | The CrossRoads Screw System implant components are |
| manufactured titanium alloy (ASTM F136) and stainless | |
| steel (ASTM F138). | |
| Substantial Equivalence: | Theoretical analysis of the worst case CrossRoads screws was performed to predict torsional and pullout strengths for the subject and predicate devices. The results demonstrate the predicted performance of the CrossRoads screws is substantially equivalent to the predicate devices. The CrossRoads Screw System possesses the same technological characteristics as the predicate devices. These include: |
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- · predicted performance,
- implant grade materials, and
- · basic design.
Therefore the fundamental scientific technology of the CrossRoads Screw System devices is the same as previously cleared devices. Therefore the CrossRoads Screw System is substantially equivalent for its intended use.
Performance Testing: Theoretical analysis of the worst case CrossRoads screws was performed to predict torsional and pullout strengths for the subject and predicate devices. The Large Screws do not result in a new worst-case within the system. The results demonstrate the predicted performance of the CrossRoads screws is substantially equivalent to the predicate devices.