(86 days)
Not Found
No
The summary describes a system of bone screws and focuses on mechanical performance testing, with no mention of AI or ML terms or functionalities.
Yes
The device is indicated for "fracture repair and fixation, reconstruction and arthrodesis of bones," which are all therapeutic interventions designed to treat or alleviate a condition.
No
The device, the CrossRoads Screw System, is indicated for fracture repair and fixation, reconstruction, and arthrodesis. These are treatment functions, not diagnostic ones.
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 is for "fracture repair and fixation, reconstruction and arthrodesis of bones." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "bone screws." These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on analysis of biological samples.
Therefore, the CrossRoads Screw System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CrossRoads Screw System is indicated for fracture repair and fixation, 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 results demonstrate the predicted performance of the CrossRoads screws is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K014154, K082320, K100359, K133713, K924018, K090675, K111994, K102903, K112885
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.
0
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
1
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 Parkway | |
| Collierville, TN 38017 USA | |
| Phone: 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 having |
| various features in a variety of diameters and lengths to accommodate | |
| differing patient anatomy. | |
| Intended 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). | |
| Predicate Devices: | Dual-Thread and Lag Screws (Vilex Inc. - K014154) |
| Dart-Fire Small and Charlotte Snap-off Screws (Wright Medical | |
| Technology - K082320, K100359 and K133713) | |
| M3-X Lag Screw (OsteoMed Corp. - K924018) | |
| Cannulated Screws and QFX Screw (Smith & Nephew - K090675 and | |
| K111994) | |
| Herbert™ and Cannulated Screw System (Zimmer, Inc. – K102903 and | |
| K112885) | |
| 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. | |
| Technological | |
| Characteristics: | The CrossRoads Screw System possesses the same technological |
| characteristics as the predicate devices. These include: | |
| • 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. | |
| Conclusion: | The CrossRoads Screw System possesses the same intended use and |
| technological characteristics as the predicate devices. Therefore the | |
| CrossRoads Screw System is substantially equivalent for its intended use. |