(150 days)
Not Found
No
The summary describes a mechanical implant system (nails and screws) for bone fractures and osteotomies. There is no mention of software, image processing, AI, ML, or data sets, which are typically associated with AI/ML medical devices.
Yes
The device, a Tapered Small Bone Nail Implant (SBNI), is indicated for use in fractures and osteotomies, which are medical treatments for conditions affecting the bones. This aligns with the definition of a therapeutic device as it treats or manages a disease or condition.
No
The provided text indicates the device is an implant for fractures and osteotomies, not a tool for diagnosis. Its intended use is described as "Tapered Small Bone Nail Implant (SBNI) is indicated for use in fractures and osteotomies," which points to a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly states it includes "Tapered Nails (straight or bowed) and Locking Screws," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating fractures and osteotomies of specific bones (fibula, radius, and ulna). This is a therapeutic use, not a diagnostic one.
- Device Description: The device is an implantable nail and screws, which are used to stabilize bones. This is a surgical/implantable device, not a diagnostic reagent or instrument used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for surgical intervention and stabilization of bone fractures and osteotomies.
N/A
Intended Use / Indications for Use
The Tapered Small Bone Nail Implant (SBNI) is indicated for use in fractures and osteotomies of the fibula, radius, and ulna.
Product codes
HSB
Device Description
The Vilex Small Bone Nail Implant System includes Tapered Nails (straight or bowed) and Locking Screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fibula, radius, and ulna.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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)
Acumed Small Bone Locking Rod System (K031438 and K071944), Biomet Titanium Intramedullary Rods-Various Styles (K982953), Kirschner (now Biomet, Inc.) Intramedullary Nail System (K854338), Arthrex Opening Wedge Osteotomy System (K973812), Arthrex Low Profile Plate and Screw System (K052614)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Vilex, Incorporated % Abraham Lavi, Ph.D. Consultant 8374 Market Street, #167 Lakewood Ranch, Florida 34202
Re: K151456
Trade/Device Name: Small Bone Nail Implant Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 28, 2015 Received: September 29, 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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,
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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K151456 - Page 1 of 1
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INDICATIONS FOR USE
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510(k) Number: K151456
DEVICE NAME: Small Bone Nail Implant (SBNI)
INDICATIONS FOR USE
The Tapered Small Bone Nail Implant (SBNI) is indicated for use in fractures and osteotomies of the fibula, radius, and ulna.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (DOE)
Page 1 of 1
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510(k) Summary Small Bone Nail Implant System K151456
| Sponsor: | Vilex, Inc.
111 Moffitt Street
McMinnville, TN 37110
Phone: (931) 474-7550
Fax: (931) 474-7551 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Abraham Lavi |
| Date Prepared: | September 22, 2015 |
| Trade Name: | Small Bone Nail Implant System |
| Common Name: | Intramedullary Fixation Rod |
| Classification
Name: | 21 CFR Section 888.3020 Rod, Fixation, Intramedullary And Accessories |
| | Device Class: |
| Product Code: | HSB/ Orthopedics |
| Predicate
Devices: | Acumed Small Bone Locking Rod System (K031438 and K071944)
Biomet Titanium Intramedullary Rods-Various Styles (K982953) and
Kirschner (now Biomet, Inc.) Intramedullary Nail System (K854338)
Arthrex Opening Wedge Osteotomy System (K973812)
Arthrex Low Profile Plate and Screw System (K052614) |
| Description of
Device: | The Vilex Small Bone Nail Implant System includes Tapered Nails (straight
or bowed) and Locking Screws. |
| Indications for
Use: | The Tapered Small Bone Nail Implant (SBNI) is indicated for use in
fractures and osteotomies of the fibula, radius, and ulna. |
| Technological
Characteristics: | The technological characteristics for the Small Bone Nail Implant System
are similar to the characteristics of the predicate devices. The sizes included
in the Small Bone Nail Implant System are similar to the range of offerings
of the predicate devices and the designs of the Small Bone Nail Implant
System are similar to the predicate devices. The materials used to
manufacture the Small Bone Nail Implant System are implant grade
materials appropriate for intramedullary nails. |
| Substantial
Equivalence: | The design features of the Small Bone Nail Implant are substantially
equivalent to the design features of other predicate devices previously cleared
for market. The claim of substantial equivalence of the Small Bone Nail
Implant System to the predicate devices is based on the comparison of the
intended use, product technical characteristics and performance
characteristics. Comparisons confirmed that the Small Bone Nail Implant is
as safe, as effective and should perform as well as or better than the predicate
devices. While the Small Bone Nail Implant System is not identical to the
predicate devices, comparisons of the subject and predicate devices
confirmed that any differences between the subject device and predicates do
not render the device NSE as there is not a new intended use; and any
differences in technological characteristics do not raise different questions of
safety and effectiveness than the predicate devices. Therefore, it is concluded
that the Small Bone Nail Implant System is substantially equivalent to the
predicate devices as outlined previously. |
| Conclusions: | While the devices in the Small Bone Nail Implant System 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
Small Bone Nail Implant System is substantially equivalent to the predicate
devices as outlined previously and should not render the subject device NSE. |
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