(123 days)
Not Found
No
The summary describes a mechanical fixation system and contains no mention of AI, ML, image processing, or data-driven algorithms.
No
Explanation: This device is an orthopedic implant for fracture repair and fixation, which is a structural support device, not a therapeutic device designed to treat or cure a disease or condition through non-structural means.
No
Explanation: The device is indicated for fracture repair, fixation, osteotomy, joint fusion, reconstruction, and arthrodesis, which are all treatment-oriented procedures, not diagnostic ones.
No
The device description explicitly states it consists of "screws in various diameters and lengths that mate with a washer nut," 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 states "fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones". This describes a surgical device used to treat conditions within the body.
- Device Description: The description of screws, washer nuts, and bicortical fixation further confirms it's a mechanical device for bone repair.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue) to provide diagnostic information. IVDs are used to diagnose diseases or conditions, monitor treatments, or screen for health issues.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device performance was characterized through torsion and static pullout testing in bone analog material. 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. Clinical data are not needed to support the safety and effectiveness of the subject device. Side-by-side performance testing demonstrates the substantial equivalence of the Bicortical Fixation Screw & Washer Nut System to the Synthes Cortex Screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face.
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
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/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 (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
2
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 |
| 124 South 600 West, Suite 100 | |
| Logan, UT 84321 | |
| Contact: | Mr. Robert Hoy |
| Director of Research | |
| Phone: (614) 448-6358 | |
| Fax: (435) 213-4878 | |
| bob@surgicalfrontiers.com | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | April 14, 2016 |
| Common Name: | Screw, Fixation, Bone |
| 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.