(42 days)
No
The device description details mechanical components for external fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is used for stabilization of fractures, osteotomy, bone deformity correction, and leg lengthening, which are all therapeutic interventions aimed at treating medical conditions.
No
The device is an external fixation system used for stabilization, arthrodesis, lengthening, and correction of bone deformities, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly lists multiple hardware components made of stainless steel and aluminum, including pins, rails, and instruments. There is no mention of software as a component of this system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as an external fixation system for stabilizing fractures, performing arthrodesis, lengthening limbs, and correcting bone deformities. These are all surgical procedures performed directly on the patient's body.
- Device Description: The components listed (pins, guidewires, rails, instruments) are all physical devices used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside or on the body) for structural support and manipulation.
N/A
Intended Use / Indications for Use
The Vilex External Fixation System is intended for external fixation with the following indications:
- · Stabilization of Fractures & Osteotomy
- Rear and Mid-foot Arthrodesis
- · Adult and Pediatric Leg Lengthening
- · Correction of Bone Deformity in Upper & Lower Extremities
Product codes
KTT, JDW
Device Description
The Dynex Micro® falls within the Vilex External Fixation System product line. The system consists of the following components:
- Half pins and pins;
- Guidewires; ●
- External fixation rails; and ●
- Instruments.
The half pins are constructed from stainless steel (ASTM F138 LVM) and are provided in multiple diameters (2.0, 2.5, 3.0, 4.0, 5.0, and 6.0 mm) and lengths (60 - 175 mm). The transfixation pins, also constructed from stainless steel, and are provided in three diameters (2.5, 3.0, and 5.0 mm) and two lengths (250 mm and 350 mm).
Guidewires are available in 1.1 mm and 1.6 mm diameter configurations and range in length from 60 - 150 mm.
The mini- and mono- rails are manufactured from stainless steel and aluminum and are provided in various sizes (100 - 300 mm) to accommodate variations in patient size.
The Dynex Micro® components are used with general and dedicated surgical instruments such as drill guides, drills, drill sleeves, wrenches, pin inserters, guide wire holders, and removal tools.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper & Lower Extremities (implied by "Correction of Bone Deformity in Upper & Lower Extremities")
Rear and Mid-foot (implied by "Rear and Mid-foot Arthrodesis")
Indicated Patient Age Range
Adult and Pediatric
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)
As the only difference between the subject and predicate devices is the product trade name, no additional performance data was submitted to demonstrate the substantial equivalence of the subject device to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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September 11, 2020
Image /page/0/Picture/1 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, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Vilex, LLC Joyce Thacker Operations Manager 111 Moffitt Street McMinnville, Tennessee 37110
Re: K202143
Trade/Device Name: Dynex Micro® Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: July 30, 2020 Received: July 31, 2020
Dear Joyce Thacker:
(NOTE: Reprocessed SUD device types require a separate attachment of the list of all models cleared in the submission. A corrected SE letter will be required if the attachment is omitted.)
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.
1
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 (OS) 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.
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202143
Device Name
Dynex Micro®
Indications for Use (Describe)
The Vilex External Fixation System is intended for external fixation with the following indications:
- · Stabilization of Fractures & Osteotomy
- Rear and Mid-foot Arthrodesis
- · Adult and Pediatric Leg Lengthening
- · Correction of Bone Deformity in Upper & Lower Extremities
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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3
510(k) Summary K202143
I. Submitter
Vilex, LLC 111 Moffitt Street McMinnville, TN 37110
Contact Person: Joyce Thacker, Operations Manager Phone: 931-474-7550 Email: joycet@vilex.com
Date Prepared: September 8, 2020
II. Device
| Device Proprietary Name: | Dynex Micro® |
|---|---|
| Common or Usual Name: | External Fixation System |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances |
| and Accessories | |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | KTT (primary), JDW (secondary) |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- X-Fix, K052196, Vilex Inc. ●
IV. Device Description
The Dynex Micro® falls within the Vilex External Fixation System product line. The system consists of the following components:
- Half pins and pins;
- Guidewires; ●
- External fixation rails; and ●
- Instruments.
The half pins are constructed from stainless steel (ASTM F138 LVM) and are provided in multiple diameters (2.0, 2.5, 3.0, 4.0, 5.0, and 6.0 mm) and lengths (60 - 175 mm). The transfixation pins, also constructed from stainless steel, and are provided in three diameters (2.5, 3.0, and 5.0 mm) and two lengths (250 mm and 350 mm).
4
Guidewires are available in 1.1 mm and 1.6 mm diameter configurations and range in length from 60 - 150 mm.
The mini- and mono- rails are manufactured from stainless steel and aluminum and are provided in various sizes (100 - 300 mm) to accommodate variations in patient size.
The Dynex Micro® components are used with general and dedicated surgical instruments such as drill guides, drills, drill sleeves, wrenches, pin inserters, guide wire holders, and removal tools.
V. Indications for Use
The Vilex External Fixation System is intended for external fixation with the following indications:
- Stabilization of Fractures & Osteotomy
- Rear and Mid-foot Arthrodesis ●
- Adult and Pediatric Leg Lengthening ●
- Correction of Bone Deformity in Upper & Lower Extremities .
Comparison of Technological Characteristics VI.
The Dynex Micro® is identical to the predicate device with respect to the indications for use, offered variants, design, materials, sterilization, and manufacturing methods.
VII. Performance Data
As the only difference between the subject and predicate devices is the product trade name, no additional performance data was submitted to demonstrate the substantial equivalence of the subject device to the predicate device.
VIII. Conclusion
As the only difference between the subject and predicate devices is the product trade name, the Dynex Micro® is substantially equivalent to the predicate device.