(447 days)
Ankle Arthrodesis, Tibio-talo-calacaneal Arthrodesis
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.
Here's an analysis of the provided 510(k) summary for the FUZE®: Intramedullary Arthrodesis Nail System, focusing on acceptance criteria and the supporting study, based only on the information provided in your input:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical performance targets (e.g., tensile strength, fatigue life thresholds). Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is framed in terms of achieving this equivalence and demonstrating mechanical integrity.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Design features comparable to predicate devices. | "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." |
| Mechanical Integrity: Sufficient for the intended application. | "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." |
| Safety and Effectiveness: Adequately supported. | "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." (This is a summary statement, not a specific performance metric, but it encapsulates the overall goal of the submission). |
| Material Compatibility: Suitable for human implanting. | "Material: Titanium Ti6Al4V, ASTM 136 or stainless steel alloy 316L ASTM 138, suitable for human implanting" (This is a material specification that inherently implies suitability for implantation, which is a form of acceptance). |
| Intended Indications for Use: Ankle Arthrodesis, Tibio-talo-calcaneal Arthrodesis. | The device is indicated for these uses, and the equivalence argument implicitly supports its ability to perform these functions similarly to predicates. The performance is that it can be used for these indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a numerical count of cadavers, sawbones, or specific test pieces. The summary mentions "cadaver, sawbones, and components tests."
- Data Provenance: The nature of the tests (engineering analysis, cadaver, sawbones, and components tests) suggests the data is likely prospective in the sense that these tests were conducted specifically for this submission to evaluate the device. The geographical origin of the data is not specified but would typically be from the manufacturer's testing facilities or contract labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the summary. The "tests" mentioned (engineering, cadaver, sawbones, components) are mechanical and material performance tests, where "ground truth" would be established by scientific measurement and engineering principles rather than expert clinical consensus in the way it applies to diagnostic devices evaluating images/data.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human judgment (e.g., reading medical images) to resolve discrepancies among multiple expert opinions in establishing a ground truth. The tests described are engineering and material performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases, and the AI's impact on their performance is evaluated. The FUZE system is an implantable orthopedic device.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study (algorithm only) was not done. This concept is also primarily applicable to AI/ML diagnostic algorithms. The FUZE is a physical medical device; its performance is evaluated through mechanical testing, material analysis, and comparison to predicate devices, not through an "algorithm only" study.
7. Type of Ground Truth Used
The "ground truth" in this context is established by:
- Engineering principles and measurements: For mechanical integrity (e.g., strength, stiffness, fatigue).
- Material specifications: Conformance to ASTM standards for Titanium and Stainless Steel.
- Comparison to predicate devices: Establishing that its design features (indications, materials, sizes, hole locations, shape) are substantially equivalent.
- Biomechanical performance: Demonstrated through cadaver and sawbones tests for its ability to compress tibi-talo-calcaneal joints.
8. Sample Size for the Training Set
Not Applicable. The FUZE system is a physical orthopedic implant, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, there is no corresponding ground truth to establish for it.
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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 accessoriesProduct 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 ofDevice: | The Vilex FUZETM is a single-piece intramedullary nail fixed to the tibia and foot with locking crossscrews for fusing the ankle joint(s). The FUZETM is a straight cannulated metallic implant offered in fivediameters 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, andinstrumentation for fixation. The screws, (offered in one diameter and various lengths), are manufacturedfrom identical materials (either stainless steel or titanium alloy, matching the implant). The targetingdevice is radio translucent, designed to lock into the FUZETM for the correct insertion of the lockingscrews. The system also includes drills, reamers, screwdrivers, guide wires and Steinman pins. |
| SubstantialEquivalence | Engineering analysis, cadaver, sawbones, and components tests confirm that the design possesses themechanical integrity necessary for this application and implant can compress the tibi-talo-calcanealjoints. The design features of the FUZETM Intramedullary Arthrodesis Nail System are substantiallyequivalent to the design features of other predicate devices previously cleared for market. The methodsused to establish equivalence are indications for use, material of construction, sizes, hole locations, andshape. The safety and effectiveness of the FUZETM is adequately supported by the substantialequivalence information, material information and analysis data provided within this PremarketNotification. |
| 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 |
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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
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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
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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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§ 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.