(447 days)
Not Found
No
The device description and summary of performance studies focus solely on the mechanical aspects of the intramedullary nail and associated instrumentation. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is an intramedullary nail used for fusing ankle joints, which is a therapeutic intervention to treat a medical condition.
No
The device description indicates it is an intramedullary nail for fusing joints, a treatment device, not a diagnostic one.
No
The device description clearly outlines a physical intramedullary nail, locking screws, and instrumentation, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Vilex FUZETM is an implantable surgical device designed to fuse bones in the ankle and foot. It is a physical object inserted into the body during surgery.
- Intended Use: The intended use is for "Ankle Arthrodesis, Tibio-talo-calcaneal Arthrodesis," which are surgical procedures to fuse joints.
- Lack of Diagnostic Function: The description does not mention any function related to testing samples or providing diagnostic information.
Therefore, based on the provided information, the Vilex FUZETM is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ankle Arthrodesis, Tibio-talo-calacaneal Arthrodesis
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Vilex FUZETM is a single-piece intramedullary nail fixed to the tibia and foot with locking cross screws for fusing the ankle joint(s). The FUZETM is a straight cannulated metallic implant offered in five diameters and various lengths in either 316L VM (ASTM 138) stainless steel or Ti6Al4V titanium alloy (ASTM 136). The FUZETM System is a modular system consisting of the implant, locking screws, and instrumentation for fixation. The screws, (offered in one diameter and various lengths), are manufactured from identical materials (either stainless steel or titanium alloy, matching the implant). The targeting device is radio translucent, designed to lock into the FUZETM for the correct insertion of the locking screws. The system also includes drills, reamers, screwdrivers, guide wires and Steinman pins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joint(s), tibia and foot, tibi-talo-calcaneal joints
Indicated Patient Age Range
Not Found
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)
Engineering analysis, cadaver, sawbones, and components tests confirm that the design possesses the mechanical integrity necessary for this application and implant can compress the tibi-talo-calcaneal joints.
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.
K090857, K021786, K043052, K051590, K091788
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.
Not Found
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
510(k) K102413: Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the FUZE®: Intramedullary Arthrodesis Nail System.
| Sponsor: | Vilex in Tennessee, Inc., 111 Moffitt St., McMinnville, TN 37110,
931-474-7550 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sylvia Southard Date: Nov 8, 2011 |
| Device Name: | FUZE®: Intramedullary Internal Fixation Nail |
| Classification: | 21 CFR 888.3020 – “Intramedullary Nail”
21 CFR 888.3030 Single/Multiple component metallic bone fixation appliances and accessories
Product Code HSB, Class II |
| Predicate Devices: | K090857 Ankle Fusion Nail (VALORTM) |
| | K021786 Titanium Ankle Arthrodesis Nail (Phoenix) |
| | K043052 TriGen Hindfoot Fusion Nail |
| | K051590 T2 Ankle Arthrodesis Nail |
| | K091788 Panta Arthrodesis Nail |
| Description of
Device: | The Vilex FUZETM is a single-piece intramedullary nail fixed to the tibia and foot with locking cross
screws for fusing the ankle joint(s). The FUZETM is a straight cannulated metallic implant offered in five
diameters and various lengths in either 316L VM (ASTM 138) stainless steel or Ti6Al4V titanium alloy
(ASTM 136). The FUZETM System is a modular system consisting of the implant, locking screws, and
instrumentation for fixation. The screws, (offered in one diameter and various lengths), are manufactured
from identical materials (either stainless steel or titanium alloy, matching the implant). The targeting
device is radio translucent, designed to lock into the FUZETM for the correct insertion of the locking
screws. The system also includes drills, reamers, screwdrivers, guide wires and Steinman pins. |
| Substantial
Equivalence | Engineering analysis, cadaver, sawbones, and components tests confirm that the design possesses the
mechanical integrity necessary for this application and implant can compress the tibi-talo-calcaneal
joints. The design features of the FUZETM Intramedullary Arthrodesis Nail System 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, hole locations, and
shape. The safety and effectiveness of the FUZETM is adequately supported by the substantial
equivalence information, material information and analysis data provided within this Premarket
Notification. |
| Material: | Titanium Ti6Al4V, ASTM 136 or stainless steel alloy 316L ASTM 138, suitable for human implanting |
| Indications for Use: | Ankle Arthrodesis, Tibio-talo-calcaneal Arthrodesis |
| Establishment Reg.
No.: | 1051526 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 1 4 2011
Vilex, Inc. % Ms. Sylvia Southard 111 Moffitt Street McMinnville, Tennessee 37110
Re: K102413
Trade/Device Name: FUZE Intramedullary Internal Fixation Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 8, 2011 Received: November 9, 2011
Dear Ms. Southard:
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
2
Page 2 – Ms. Sylvia Southard
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 vours.
Erin S. Keith
Mark N. Melkerson · Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K102413
Device Name: FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
Indications For Use:
The Vilex FUZE has the following Indications for Use
Ankle Arthordesis, Tibio-talo-calacaneal Arthrodesis
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ivision Sign-Oft) ivision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102413
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