(110 days)
No
The device description and performance studies focus on the mechanical properties and design of bone screws and associated instrumentation, with no mention of AI or ML.
Yes
The device is indicated for fracture fixation, osteotomies, reconstruction procedures, and arthrodesis, which are therapeutic interventions.
No
Explanation: The device is described as a system of screws and associated instrumentation for fixation, osteotomies, reconstruction, and arthrodesis of bones, which are therapeutic and reconstructive procedures, not diagnostic ones.
No
The device description clearly states that the device consists of physical screws made from titanium and requires specific instrumentation made from stainless steel and aluminum. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are described as implants made of titanium, used for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle. These are surgical procedures performed directly on the body, not tests performed on specimens outside the body.
- Intended Use: The intended use clearly states their purpose in surgical procedures on bones, not for diagnostic testing of biological samples.
The information provided describes a surgical implant system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.
Product codes
HWC
Device Description
The TITANEX™MICROBEAMS and the TITANEX™ ARTEMIS screw systems contain fully threaded screws as a reconstruction solution providing various diameters of cannulated screws.
The TITANEX™ MICROBEAM's are provided in diameters of Ø2.0mm, Ø2.5mm, and the TITANEX™ ARTEMIS screws are Ø3.0mm, and Ø4.0mm. The Screws are a fully threaded design and come in variable lengths from 16mm - 70mm. The Ø2.0mm family: 16mm -50mm, for the Ø2.5mm family: 16mm - 50 mm, for the Ø3.0mm family: 12mm - 50mm, for the Ø4.0mm family: 16mm - 70mm. All screws are provided in 2mm increments.
All implants' components are manufactured from titanium (Ti-6AI-4V, ASTM F136).
Specific instrumentation including wires, drills, depth gages, and torx drivers are required for use with the system. The TITANEX™ Screws instruments are manufactured from stainless steel and aluminum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones in the foot and ankle
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)
Mechanical testing per ASTM F543-17 - Insertion Torque, Removal Torque, Pull-out Force, Ultimate Torque.
Computational Analysis - Cross sectional Analysis, Axial Pullout per Chapman et al.
In addition, cleaning and sterilization validations, performed in accordance with ANSI/AAMI/ISO 17665-1, from the applicant's own predicate device were leveraged.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 11, 2023
Vilex LLC Brock Johnson President 111 Moffitt Street McMinnville, Tennessee 37110
Re: K231504
Trade/Device Name: TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS 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: May 23, 2023 Received: May 24, 2023
Dear Brock Johnson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tejen D. Soni -S
For
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231504
Device Name
TITANEX™ MICROBEAM Screw System and TITANEX™ ARTEMIS Screw System
Indications for Use (Describe)
The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
. Submitter
Vilex LLC 111 Moffit St. McMinnville, TN 37110
Contact Person: Brock Johnson, President Phone: (801) 916-4157 Date Prepared May 5th, 2023
II. Device
| Device Proprietary Name: | TITANEX™ MICROBEAM Screw System,
TITANEX™ ARTEMIS Screw System |
|--------------------------|-------------------------------------------------------------------|
| Common or Usual Name: | Bone Fixation Fastener |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HWC |
| Device Classification | II |
= Predicate Device
Substantial equivalence for the TITANEX™ Screws is claimed to the following devices:
- Vilex Cannulated Bone Screw / DuVal Cannulated Screw, K991197 (Primary ● Predicate)
- Vilex FUZE®: Intramedullary Internal Fixation Nail, K102413 (Reference Device) .
IV. Device Description
The TITANEX™MICROBEAMS and the TITANEX™ ARTEMIS screw systems contain fully threaded screws as a reconstruction solution providing various diameters of cannulated screws.
The TITANEX™ MICROBEAM's are provided in diameters of Ø2.0mm, Ø2.5mm, and the TITANEX™ ARTEMIS screws are Ø3.0mm, and Ø4.0mm. The Screws are a fully threaded design and come in variable lengths from 16mm - 70mm. The Ø2.0mm family: 16mm -50mm, for the Ø2.5mm family: 16mm - 50 mm, for the Ø3.0mm family: 12mm - 50mm, for the Ø4.0mm family: 16mm - 70mm. All screws are provided in 2mm increments.
All implants' components are manufactured from titanium (Ti-6AI-4V, ASTM F136).
Specific instrumentation including wires, drills, depth gages, and torx drivers are required for use with the system. The TITANEX™ Screws instruments are manufactured from stainless steel and aluminum.
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V. Indications for Use
The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.
VI. Comparison of Technological Characteristics
General Comparison: The subiect device is labeled for the similar indications as the primary predicate device (K991197). Both devices are prescription-only medical solutions.
Implant Comparison: Both the subject and primary predicate are made of Titanium Alloy (ASTM F136). Both contain a headed screw design with cannulation. The predicate is partially threaded, while the subject is fully threaded, enhancing purchase and strength. Both the subject and predicate devices are marketed as nonsterile devices. The screw sizes for the subject range from ø2.0mm x 6mm to ø4.0mm x 70mm, which are similar to those of the predicate.
Discussion
As seen above, the subject and predicate devices are equivalent in their core characteristics. Both systems are cannulated screw designs made from titanium alloy that share equivalent indications.
The Subject devices are a headless design whereas the Predicate is a headed design. The subject devices also introduce additional size options.
The technological differences between the subject device and predicate devices do not raise different questions of safety or effectiveness and substantial equivalence is demonstrated through the testing described below.
VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination:
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- Mechanical testing per ASTM F543-17 ●
- o Insertion Torque
- Removal Torque o
- Pull-out Force o
- o Ultimate Torque
- Computational Analysis .
- o Cross sectional Analysis
- Axial Pullout per Chapman et al.
In addition, cleaning and sterilization validations, performed in accordance with ANSI/AAMI/ISO 17665-1, from the applicant's own predicate device were leveraged.
VIII. Conclusion
The information provided above supports the claim that the TITANEX™ Screw System, consisting of the TITANEX™ MICROBEAMS and TITANEX™ ARTEMIS screws are sustainably equivalent to the predicate device. Although minor differences in design exist between the subject and predicate device, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the TITANEX™ Screw Systems are substantially equivalent to the predicate devices.