(317 days)
No
The device description focuses on the material and intended use of external fixation components, with no mention of AI or ML capabilities.
No
The device is used for external fixation, which is a supportive and corrective measure for skeletal issues, not a therapeutic treatment.
No
The device is described as an external fixation system (half pins and wires) used for the stabilization of fractures, arthrodesis, leg lengthening, and correction of bone deformity. These are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly states it includes "medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA)," which are physical hardware components.
Based on the provided information, the Vilex X-Fix is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function in stabilizing fractures, performing arthrodesis, leg lengthening, and correcting bone deformities. These are all procedures performed on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is described as medical grade stainless steel pins and wires used with external fixation systems. This aligns with surgical implants and external fixation devices, not diagnostic tools that analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Vilex X-Fix does not fit this description.
N/A
Intended Use / Indications for Use
The Vilex X-Fix is intended for external fixation with the following indications:
-
- Stabilization of Fractures & Osteotomy
-
- Rear & Mid-foot Foot Arthrodesis
-
- Adult and Pediatric Leg Lengthening
-
- Correction of Bone Deformity in Upper & Lower Extremities
Product codes (comma separated list FDA assigned to the subject device)
JDW
Device Description
This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rear & Mid-foot, Upper & Lower Extremities
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)
Not Found
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.
K023921, K033289, K974186, K955848, K061493, K080071, K093550, K083912
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.
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
510(k) Summary K132820
JIII 2 3 2014
| Sponsor: | Vilex in Tennessee, Inc.
111 Moffitt St.
McMinnville, TN 37110
931-474-7550 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Abraham Lavi |
| Date Prepared: | June 16, 2014 |
| Trade Name: | Ultima HA Coated Half Pins & Wires |
| Common Name: | Bone fixation fastener |
| Classification: | 21 CFR 888.3040 - Smooth or threaded memtallic bone fastener |
| Product Code: | JDW/Orthopedics, Class II |
| Predicate Devices: | Smith & Nephew Jet-X Half Pins (HA Coated) (K023921, K033289)
Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating
(K974186) and Pins used with Mini Rail System (K955848)
Stryker Apex Pins (K061493)
Wright Medical Sidekick Rail Half Pins (K080071)
SBi Mini Rail Half Pins by SBI (K093550)
Treu Kirschner Wires by Treu-Instrumente GMBH (K083912) |
Medical Facets Kirschner Wires by Medical Facets (K112727)
Description of Device:
This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.
Indications for Use:
The Vilex X-Fix is intended for external fixation with the following indications:
-
- Stabilization of Fractures & Osteotomy
-
- Rear & Mid-foot Foot Arthrodesis
-
- Adult and Pediatric Leg Lengthening
- Correction of Bone Deformity in Upper & Lower Extremities
Technological Characteristics:
The technological characteristics for the Ultima HA Coated Half Pins are Wires are the same as the characteristics of the predicate devices. All of the sizes included in the Vilex Ultima HA Coated Half Pin and Wire system are within the range of offerings of the predicate devices and the designs of the Vilex devices are similar to the predicate devices. The materials used to manufacture the Vilex Ultima devices are the same as those used to manufacture the predicate devices.
Substantial Equivalence
The design features of the Ultima HA Coated Half Pins & Wires are substantially equivalent to the design features of other predicate devices previously cleared for market. The methods used to establish equivalence are indications for use, material of construction, sizes, and shapes. The safety and effectiveness of the Ultima HA Coated Half Pins & Wires are adequately supported by
1
510(k) Summary K132820
the substantial equivalence information, material information and analysis data provided within this Premarket Notification. Therefore, it is concluded that the Ultima HA Coated Half Pins and Wires are substantially equivalent to the noted predicate devices.
Conclusions
While the Ultima HA Coated Half Pins and Wires are not identical to the predicate devices, any differences that may exist do not significantly affect device safety and effectiveness. In addition, the differences do not add new or increased risks and complications. Therefore, it is concluded that the Ultima HA Coated Half Pins and Wires are substantially equivalent to the predicate devices as outlined previously and should not render the subject device NSE.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 23, 2014
Vilex, Incorporated Dr. Abraham Lavi President 7214 Lake Forest Glen Lakewood Ranch, Florida 34202
Re: K132820
Trade/Device Name: Ultima HA Coated Half Pins and Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW Dated: June 19, 2014 Received: June 23, 2014
Dear Dr. Lavi:
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
3
Page 2 - Dr. Abraham Lavi
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" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours, Lori A. Wigqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Vilex Inc. The logo consists of the word "VILEX" in large, bold, black letters, with the "EX" part of the word being stylized. Below the logo, there is text that reads "Manufacturer of Vilex TM bone implants, Power equipment & surgical instruments."
Phone: Fax: www.vilex.com
(931) 474-7550 (931) 474-7551
111 Moffitt Street McMinnville, TN 37110 USA E-mail: info@vilex.com
INDICATIONS FOR USE
510(k) NUMBER: K132820
DEVICE NAME: Ultima HA Coated Half Pins and Wires
INDICATIONS FOR USE:
The Vilex X-Fix is intended for external fixation with the following indications:
-
- Stabilization of Fractures & Osteotomy
-
- Rear & Mid-foot Foot Arthrodesis
-
- Adult and Pediatric Leg Lengthening
-
- Correction of Bone Deformity in Upper & Lower Extremities
Prescription Use ਮ (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (BOE) (ODE)
Page 1 of 1
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices