(284 days)
The EzFuze Implants have 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 EzFuze Implant System includes single-piece devices intended for the fixation of PIP joints in lesser toes and digits. Two styles are offered: EzFuze Implant with barbed prongs on both ends and Hybrid EzFuze Implant with a screw design at one end and the other end includes barbed prongs. The EzFuze and Hybrid EzFuze Implants are offered straight or with a 10° bend.
This document is a 510(k) summary for the EzFuze™ Implant System. It outlines the device's indications for use, technological characteristics, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance metrics, or any study details that would typically be described in an AI/algorithm-based device submission.
This is a submission for a physical medical device (an implant for bone fixation), not an AI-powered software or diagnostic tool. Therefore, the questions related to AI device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the content provided.
Based on the provided text, I cannot provide the requested information because the document describes a physical medical implant, not an AI software/device.
To answer your request, I would need a document related to an AI/algorithm-based medical device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2015
Vilex (in Tennessee), Incorporated % Abraham Lavi, Ph.D. Consultant Vilex, Incorporated 8374 Market Street, #167 Lakewood Ranch, Florida 34202
Re: K150211
Trade/Device Name: EzFuze™ Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 25, 2015 Received: September 28, 2015
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
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" (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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for Vilex Inc. The logo consists of the word "VILEX" in red, with a red box around it. Below the logo, it says "Manufacturer of Vilex™ bone implants, Power equipment & surgical instruments".
Phone: www.vilex.com
Fax:
(931) 474-7550 (931) 474-7551
111 Moffitt Street McMinnville, TN 37110 USA E-mail: info@vilex.com
INDICATIONS FOR USE
510(k) NUMBER:
DEVICE NAME: EzFuze™ Implant System
INDICATIONS FOR USE:
The EzFuze Implants have the following Indications for Use:
Fixation of osteotomies and reconstruction of the 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)
Page 1 of 1
{3}------------------------------------------------
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 EzFuze Implant System
| Sponsor: | Vilex in Tennessee, Inc |
|---|---|
| Contact Person: | Abraham Lavi |
| Date Prepared: | September 25, 2015 |
| Trade Name: | EzFuze Implant System |
| 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: | Trident Fusion Implant by Vilex (K141937)SmartToe and X-Fuse by Styker (K070598 and K112197)OSSplate Hammerlock by BioMedical Enterprises (K091951 and K131640)DigiFuse by Metasurg (K111536)eZ-Staple Superelastic Bone Fixation Staple by Vilex (K112837)Newdeal K-wire by Newdeal (K022599) |
| Description ofDevice: | The Vilex EzFuze Implant System includes single-piece devices intended for the fixation ofPIP joints in lesser toes and digits. Two styles are offered: EzFuze Implant with barbedprongs on both ends and Hybrid EzFuze Implant with a screw design at one end and the otherend includes barbed prongs. The EzFuze and Hybrid EzFuze Implants are offered straight orwith a 10° bend. |
| Indications forUse: | The EzFuze Implants have 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 EzFuze Implant System are the same as thecharacteristics of the predicate devices. All of the sizes included in the Vilex EzFuzeImplant system are within the range of offerings of the predicate devices and the designs ofthe EzFuze devices are similar to the predicate devices. The materials used to manufacturethe EzFuze Implants are the same as those used to manufacture the predicate devices. |
| SubstantialEquivalence | The design features of the EzFuze Implant System 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 EzFuze Implant System are adequately supported by thesubstantial equivalence information, material information and analysis data provided withinthis Premarket Notification. Therefore, it is concluded that the EzFuze Implant System issubstantially equivalent to the noted predicate devices. |
| Conclusions: | While the EzFuze Implant System is 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 EzFuze Implant System is substantially equivalent to the predicate devices as outlined previously and should not render the subject device NSE. |
{4}------------------------------------------------
510(k) Summary EzFuze Implant System
§ 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.