(63 days)
No
The summary describes a mechanical external fixation system with HA-coated pins and wires, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is described as "intended for external fixation" to stabilize fractures, correct deformities, and perform leg lengthening, all of which are considered therapeutic interventions.
No
The device, Vilex X-Fix, is described as intended for external fixation to stabilize fractures, perform arthrodesis, and correct bone deformities, which are all treatment-oriented functions rather than diagnostic ones.
No
The device description explicitly states that the submission includes physical components: "medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA)." This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for external fixation to stabilize fractures, perform arthrodesis, lengthen limbs, and correct bone deformities. These are all procedures performed on the body (in vivo).
- Device Description: The device is described as stainless steel half pins and wires used with external fixation systems. These are physical implants/components used in surgical procedures.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided strongly indicates this is a surgical device used for orthopedic procedures, not an in vitro diagnostic device.
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
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Ultima HA Coated Half Pins and Wires by Vilex (K132820)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2017
Vilex in Tennessee, Inc. % Dr. Abraham Lavi Consultant Vilex, Inc. 8374 Market Street, #167 Lakewood Ranch, Florida 34202
Re: K163487
Trade/Device Name: Ultima HA Coated Half Pins And Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW Dated: November 21, 2016 Received: December 12, 2016
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "VILEX" in red font inside a red rectangular box. The letters are bold and sans-serif. There is a registered trademark symbol to the right of the letter X.
111 Moffitt Street • McMinnville, TN 37110 Toll Free 800-521-5002 • Phone 931-474-7550 • Fax 931-474-7551 Email: info@vilex.com • www.vilex.com
"We'll Wait on You Hand and Foot"
INDICATIONS FOR USE
510(k) NUMBER: K163487
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
X Prescription Use (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (DOE)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for VILEX, which is displayed in red font. The letters are bold and stylized, with the 'V' having a sharp angle and the 'X' extending beyond the other letters. The logo is enclosed in a red rectangular border, and a small circled 'R' symbol is present near the bottom right corner of the 'X'.
"We'll Wait on You Hand and Foot"
Vilex in Tennessee, Inc.
111 Moffitt Street • McMinnville, TN 37110 Toll Free 800-521-5002 • Phone 931-474-7550 • Fax 931-474-7551 Email: info@vilex.com • www.vilex.com
510(k) Summary K163487
| Sponsor: | Vilex in Tennessee, Inc. |
|---|---|
| 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 metallic bone fastener |
| Product Code: | JDW/Orthopedics, Class II |
| Predicate Devices: | Ultima HA Coated Half Pins and Wires by Vilex (K132820) |
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 Modified Ultima HA Coated Half Pins and Wires are the same as the characteristics of the predicate devices. All of the sizes included in the Vilex Modified 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. In addition, pyrogen testing has been conducted and has confirmed that the device is non-pyrogentic.
Substantial Equivalence
The design features of the Modified Ultima HA Coated Half Pins and 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, and sizes. The safety and effectiveness of the Modified Ultima HA Coated Half Pins and Wires are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification. Therefore, it is concluded that the Modified Ultima HA Coated Half Pins and Wires are substantially equivalent to the noted predicate devices.
4
Vilex in Tennessee, Inc.
Image /page/4/Picture/2 description: The image shows the word "VILEX" in red font. The letters are stylized, with the top of the "V" extending over the "I" and "L". The word is enclosed in a red rectangular border. There is a registered trademark symbol to the bottom right of the word.
"We'll Wait on You Hand and Foot"
111 Moffitt Street • McMinnville, TN 37110 Toll Free 800-521-5002 • Phone 931-474-7550 • Fax 931-474-7551 Email: info@vilex.com • www.vilex.com
510(k) Summary K163487
Conclusions
While the Modified 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 Modified 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.