(55 days)
The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.
The Vilex Trident Fusion Implant is a single-piece cannulated bone screw intended for the fixation of PIP joints in lesser toes and digits. The device is offered straight or with a 10° bend at the joint. It is available in either stainless steel or titanium.
The provided text is a 510(k) Summary for the Vilex Trident™ Fusion Implant. This document is a premarket notification to the FDA, demonstrating that a new device is as safe and effective as a legally marketed predicate device.
It does not contain information about acceptance criteria, device performance, or human study results. The document focuses on establishing substantial equivalence based on indications for use, material, sizes, shapes, and technological characteristics compared to predicate devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding studies with human participants, expert ground truth, sample sizes, or MRMC studies, as none of this information is present in the provided text.
The closest information to "device performance" is the statement repeated under "Technological Characteristics" and "Substantial Equivalence" that: "The technological characteristics for the Trident Fusion Implant are the same as the characteristics of the predicate devices." and "The design features of the Trident Fusion Implant are substantially equivalent to the design features of other predicate devices previously cleared for market." This implies that its performance is expected to be similar to legally marketed devices.
The document states that "The safety and effectiveness of the Trident Fusion Implant are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." However, the details of this "analysis data" proving safety and effectiveness are not included in the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be connected.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2014
Vilex in Tennessee Inc. % Mr. Abraham Lavi, PhD Vilex. Inc. 8374 Market Street, Suite 167 Lakewood Ranch, Florida 34202
Re: K141937
Trade/Device Name: Trident™ Fusion Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: July 23, 2014 Received: July 25, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Abraham Lavi, PhD
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours.
Lori A. Wiggins -S
for 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/1 description: The image shows the logo for Vilex Inc. The logo is red and features the word "VILEX" in a stylized font inside of a red box. Below the logo is the text "Manufacturer of Vilex™ 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: K141937
DEVICE NAME: Trident™ Fusion Implant
INDICATIONS FOR USE:
The Trident Fusion Implant has the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.
Prescription Use × (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (DOE)
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Image /page/3/Picture/0 description: The image shows the logo for Vilex Inc. The logo consists of the word "VILEX" in large, red, bold letters, with the letters connected to form a rectangular shape. Below the logo, the text reads "Manufacturer of Vilex™ 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
510(k) Summary Trident Fusion Implant K141937
| Sponsor: | Vilex in Tennessee, Inc |
|---|---|
| Contact Person: | Abraham Lavi |
| Date Prepared: | September 4, 2014 |
| Trade Name: | Trident Fusion Implant |
| Common Name: | Threaded metallic bone fixation fastener |
| ClassificationName: | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Product Code: | HWC/ Orthopedics, Class II |
| Predicate Devices: | K111536K120645, K101165DigiFuse, MetaSurgPro-Toe, Wright Medical |
| K022599K Wire, Newdeal | |
| K052736K-Wire, Arthrex | |
| Description ofDevice: | The Vilex Trident Fusion Implant is a single-piece cannulated bone screw intended for thefixation of PIP joints in lesser toes and digits. The device is offered straight or with a 10° bendat the joint. It is available in either stainless steel or titanium. |
| Indications forUse: | The Trident Fusion Implant has the following Indications for Use:Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers followingcorrection procedures for hammertoe, claw toe, mallet toe, and other deformities of the feetand hands. |
| TechnologicalCharacteristics: | The technological characteristics for the Trident Fusion Implant are the same as thecharacteristics of the predicate devices. All of the sizes included in the Vilex Trident FusionImplant system are within the range of offerings of the predicate devices and the designs ofthe Trident devices are similar to the predicate devices. The materials used to manufacturethe Trident Fusion Implants are the same as those used to manufacture the predicate devices. |
| SubstantialEquivalence | The design features of the Trident Fusion Implant are substantially equivalent to the designfeatures of other predicate devices previously cleared for market. The methods used toestablish equivalence are indications for use, material of construction, sizes, and shapes. Thesafety and effectiveness of the Trident Fusion Implant are adequately supported by thesubstantial equivalence information, material information and analysis data provided withinthis Premarket Notification. Therefore, it is concluded that the Trident Fusion Implants aresubstantially equivalent to the noted predicate devices. |
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510(k) Summary Triden Fusion Implant
| Conclusions: | While the Trident Fusion Implants 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 Trident Fusion Implants are substantially equivalent to the predicate devices as outlined previously and should not render the subject device NSE. |
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§ 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.