(58 days)
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.
The CrossRoads Screw System is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy.
This document describes the CrossRoads Screw System, a bone fixation fastener. The acceptance criteria and the study that proves the device meets those criteria are detailed below, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Torsional Strength | Predicted torsional strengths for the subject device are substantially equivalent to the predicate devices. |
| Pullout Strength | Predicted pullout strengths for the subject device are substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes "theoretical analysis" and "predicted performance" rather than physical testing on a 'test set' in the traditional sense of a clinical or laboratory study with a distinct sample size. The analysis appears to be computational/theoretical in nature.
- Sample Size: Not explicitly stated as a numerical sample size for a "test set" of physical devices. The analysis was performed on "worst case CrossRoads screws." This implies a selection of device configurations that are considered most challenging from an engineering perspective, rather than a random sample.
- Data Provenance: The study is described as "theoretical analysis." This suggests the data is derived from engineering calculations and modeling, rather than empirical data from human subjects or physical tests on manufactured devices that would have a country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this type of engineering performance study (torsional and pullout strength) is based on established engineering principles, material properties (ASTM F136 titanium alloy and ASTM F138 stainless steel), and calculation methods. It does not involve expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The study relies on calculated engineering values.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the mechanical properties of a medical device (screws) through theoretical analysis, not on the interpretation of medical images or clinical effectiveness where human readers would be involved.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is typically relevant for AI/ML-based diagnostic devices. In the context of a mechanical device like a screw system, the "standalone" performance refers to its intrinsic mechanical properties as determined by the theoretical analysis. The study described is precisely a standalone performance assessment of the device's predicted mechanical characteristics (torsional and pullout strengths) without human intervention in the performance itself (though humans designed the device and conducted the analysis).
7. The Type of Ground Truth Used
The "ground truth" for this study is based on:
- Established engineering principles and material science.
- Calculated values derived from theoretical models for torsional and pullout strengths.
- Performance of legally marketed predicate devices (K143039 CrossRoads Screw System, K000080 and K024060 Stryker Asnis III Screw System), which serve as a benchmark for "substantial equivalence."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML study that uses a "training set." The study involves theoretical engineering analysis.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of engineering performance study.
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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
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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 (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 (previouslyOrthoDiscovery Group LLC)6055 Primacy Parkway, Suite 140Memphis, TN 38119 USAPhone: 901.221.8406 |
| Primary Contact: | Vernon Hartdegen, Sr. VP of Operations901.221.8406Vhartdegen@crextremity.com |
| Trade Name: | CrossRoads Screw System |
| Common Name: | Screw System |
| Classification: | Class II |
| Regulation Number: | 888.3040, Smooth or threaded metallic bone fixationfastener |
| Panel: | Orthopedic |
| Product Code: | HWC |
| Predicate Devices: | K143039 CrossRoads Screw SystemK000080 and K024060 Stryker Asnis III Screw System |
| Device Description: | The CrossRoads Screw System is comprised of bonescrews having various features in a variety of diameters andlengths to accommodate differing patient anatomy. |
| Indications for Use: | The CrossRoads Screw System is indicated for fracturerepair and fixation, osteotomy, joint fusion, reconstructionand arthrodesis of bones appropriate for the size of thedevice. |
| Materials: | The CrossRoads Screw System implant components aremanufactured titanium alloy (ASTM F136) and stainlesssteel (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.
§ 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.