(31 days)
No
The device description lists mechanical components and instruments for external fixation. While it mentions software for pre-operative planning (K151881), the summary does not describe this software as incorporating AI/ML, and the core device itself is purely mechanical.
Yes
The device is described as an external fixation system intended for therapeutic purposes such as stabilizing fractures, correcting bone deformities, and performing adult and pediatric leg lengthening.
No
This device, the Vilex External Fixation System, is described as a system for external fixation used for stabilization, arthrodesis, leg lengthening, and correction of bone deformity. It is a treatment device, not one designed to diagnose a condition. While it mentions "Ball Markers for X-Ray" and the "P&C CORA software (K151881) may be used in conjunction ... to assist in pre-operative planning," these aspects are related to guiding the treatment and assessing its outcome, rather than making an initial diagnosis.
No
The device description explicitly lists numerous hardware components, including rings, footplates, arches, pins, wires, struts, plates, posts, hinges, washers, support rods, linear distractors, instruments, and ball markers. While software (P&C CORA software) is mentioned as potentially being used in conjunction with one of the systems, the core device being described is a physical external fixation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "external fixation" for various orthopedic procedures (fractures, osteotomy, arthrodesis, leg lengthening, deformity correction). This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The components described are all physical parts used to build an external fixation frame (rings, pins, wires, struts, instruments). These are used on the patient's body, not to test samples from the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition in vitro.
The mention of "Ball Markers for X-Ray" and "X-Ray" as an input imaging modality relates to the use of the device in conjunction with imaging for planning and monitoring, but the device itself is not performing a diagnostic test.
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® Ring Fixation System and Diametrix® Ring Fixation System fall within the Vilex External Fixation System product line. The systems consist of the following components:
- Dynex dynamic external fixation components (rings, footplates, and arches) or Diametrix static external fixation components (rings, footplates, and arches);
- Half pins and wires (regular and HA coated);
- Ball Markers for X-Ray;
- External fixation assembly hardware (e.g. wire fixation bolts, half pin bolts, struts, plates and posts, hinges, washers, support rods, and linear distractors); and
- Instruments (e.g. drills. drivers. tensioners. cutters, and benders).
The Dynex® Ring Fixation System components can be used as an external fixation and hexapod system, when configured with two or more rings and telescoping struts. The P&C CORA software (K151881) may be used in conjunction with the Dynex® Ring Fixation System to assist in pre-operative planning.
The Diametrix® Ring Fixation System components are traditional ring fixation components with frames that utilize tensioned wires and half pins.
Both systems utilize the same external fixation assembly hardware and instruments.
The Dynex rings, manufactured from aluminum, are offered in Full, 5/8, half and 3/8 sizes with footplates. The rings are circular with concentric inner and outer holes which provides versatility for hardware fixation points.
The Diametrix rings, manufactured from aluminum, are offered in in Full, 5/8, Half, and 3/8 sizes with footplates. The rings are tabbed which allows for multiple connection points and minimizes hardware interference.
The half pins and wires are constructed from stainless steel (ASTM F138 LVM). The coated half pins and wires are coated with Hydroxyapatite (HA). The half pins (Ø 3.0, 4.0, 4.5, 5.0, 6.0 mm) are provided in multiple lengths (60 – 200 mm) and are provided in sterile and non-sterile packaging. The wires are available in multiple designs (wire sharp bayonet, pear wire sharp bayonet, and wire bayonet olive) and are provided in 1.2. 1.5. and 1.8 mm diameters and range in length from 250 – 400 mm. The HA coated wires are provided sterile.
The external fixation rings, footplates, arches, struts, and assembly accessories are manufactured from stainless steel and anodized aluminum and are provided in various sizes to accommodate variations in patient size.
These components can be combined to create various frame assemblies.
The instruments and ball markers for X-Ray are manufactured from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray (Ball Markers for X-Ray)
Anatomical Site
Upper & Lower Extremities, Rear and Mid-foot
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Prescription Use
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 differences between the subject and predicate devices are the product trade names, 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)
K052196, K151881, K132820, K163487
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.
0
August 24, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vilex, LLC Joyce Thacker Operations Manager 111 Moffitt Street McMinnville, Tennessee 37110
Re: K202054
Trade/Device Name: Dynex Ring Fixation System, Diametrix Ring Fixation System 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 24, 2020 Received: July 24, 2020
Dear Joyce Thacker:
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.
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
1
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 mediation-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. Acting 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)
K202054
Device Name Dynex® Ring Fixation System Diametrix® Ring Fixation System
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
I. Submitter
Vilex, LLC 111 Moffitt Street McMinnville, TN 37110
Contact Person: Joyce Thacker, Operations Manager Phone: 931-474-7550 Date Prepared: August 21, 2020
II. Device
| Device Proprietary Name: | Dynex® Ring Fixation System and Diametrix® Ring Fixation System |
|---|---|
| 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. ●
- X-Fix Line Additions, K151881, Vilex in Tennessee, Incorporated ●
- Vilex Ultima External Fixation System with HA Coated Pins and Wires, K132820, Vilex, ● Inc.
- Ultima HA Coated Half Pins and Wire, K163487, Vilex In Tennessee, Inc. ●
IV. Device Description
The Dynex® Ring Fixation System and Diametrix® Ring Fixation System fall within the Vilex External Fixation System product line. The systems consist of the following components:
- Dynex dynamic external fixation components (rings, footplates, and arches) or Diametrix static external fixation components (rings, footplates, and arches);
- Half pins and wires (regular and HA coated); ●
- Ball Markers for X-Ray; ●
4
K202054
- . External fixation assembly hardware (e.g. wire fixation bolts, half pin bolts, struts, plates and posts, hinges, washers, support rods, and linear distractors); and
- Instruments (e.g. drills. drivers. tensioners. cutters, and benders).
The Dynex® Ring Fixation System components can be used as an external fixation and hexapod system, when configured with two or more rings and telescoping struts. The P&C CORA software (K151881) may be used in conjunction with the Dynex® Ring Fixation System to assist in pre-operative planning.
The Diametrix® Ring Fixation System components are traditional ring fixation components with frames that utilize tensioned wires and half pins.
Both systems utilize the same external fixation assembly hardware and instruments.
The Dynex rings, manufactured from aluminum, are offered in Full, 5/8, half and 3/8 sizes with footplates. The rings are circular with concentric inner and outer holes which provides versatility for hardware fixation points.
The Diametrix rings, manufactured from aluminum, are offered in in Full, 5/8, Half, and 3/8 sizes with footplates. The rings are tabbed which allows for multiple connection points and minimizes hardware interference.
The half pins and wires are constructed from stainless steel (ASTM F138 LVM). The coated half pins and wires are coated with Hydroxyapatite (HA). The half pins (Ø 3.0, 4.0, 4.5, 5.0, 6.0 mm) are provided in multiple lengths (60 – 200 mm) and are provided in sterile and non-sterile packaging. The wires are available in multiple designs (wire sharp bayonet, pear wire sharp bayonet, and wire bayonet olive) and are provided in 1.2. 1.5. and 1.8 mm diameters and range in length from 250 – 400 mm. The HA coated wires are provided sterile.
The external fixation rings, footplates, arches, struts, and assembly accessories are manufactured from stainless steel and anodized aluminum and are provided in various sizes to accommodate variations in patient size.
These components can be combined to create various frame assemblies.
The instruments and ball markers for X-Ray are manufactured from stainless steel.
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 ●
5
VI. Comparison of Technological Characteristics
The Dynex® Ring Fixation System and Diametrix® Ring Fixation System are identical to the predicate devices with respect to indications for use, offered variants, design, materials, sterilization, and manufacturing methods.
Performance Data VII.
As the only differences between the subject and predicate devices are the product trade names, no additional performance data was submitted to demonstrate the substantial equivalence of the subject device to the predicate device.
VIII. Conclusion
As the only differences between the subject and predicate devices are the product trade names, the Dynex® Ring Fixation System and Diametrix® Ring Fixation System are substantially equivalent to the predicate devices.