(58 days)
Not Found
No
The description focuses on mechanical components and temporary bone stabilization, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for temporary bone stabilization in trauma and orthopedic procedures, which directly addresses medical conditions and aims to improve a patient's health.
No
Explanation: The device is described as a system for temporary bone stabilization, which is a therapeutic intervention, not a diagnostic one. Its purpose is to stabilize bones, not to identify or characterize medical conditions.
No
The device description explicitly lists physical components such as screws, clamps, rods, and a foot unit, indicating it is a hardware-based external fixation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment." This is a surgical/orthopedic procedure performed directly on the patient's body.
- Device Description: The device description details components like screws, clamps, rods, and a foot unit, all designed for external fixation of bone. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
Temporary stabilization of the tibia and foot in conditions and procedures, such as:
- comminuted open or closed tibial fractures
- polytrauma patient
- damage control orthopedics for fractures with severe soft tissue injuries
- peri-prosthetic or peri-implant fractures
- joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
- intra-operative fracture reduction
- intermediate stabilization in staged surgery
- infected non-union pending second stage treatment bone-loss or other reconstructive procedures
The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws. Galaxy Fixation System and bicortical screws must be used when Galaxy UNYCO is not indicated or available. The product is indicated for non-weight-bearing use.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Orthofix Galaxy UNYCO System consists of a series of sterile kits that include UNYCO Cancellous Screws, Large Multiscrew Clamps for UNYCO Screws, Rods Ø 12mm, a radiolucent Foot Unit and specific application tools. External fixation systems are modular, therefore different frame configurations are possible. The Orthofix components in the Galaxy UNYCO System are not intended to replace normal healthy bone or to withstand the stresses of weight bearing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limb, tibia, foot
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)
The potential hazards have been evaluated and controlled through a Risk Management Plan.
All testing met or exceeded the requirements as established by the test protocols and applicable standards. A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure. The Subject device was therefore found to be substantially equivalent to the predicate devices. Clinical data was not needed to support the safety and effectiveness of the Subject Device.
The following mechanical testing was performed:
ASTM F 1541 "Standard Specification and Test Methods for External Skeletal Fixation Devices" MRI compatibility testing was also conducted per: ASTM F2182 "Standard test method for measurement of radio frequency induced heating near passive implants during magnetic resonance imaging"
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2016
Orthofix SRL % Ms. Cheryl Wagoner Consultant Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408
Re: K153233
Trade/Device Name: Galaxy UNYCO System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: November 6, 2015 Received: November 9, 2015
Dear Ms. Wagoner:
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
1
(21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical 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 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K153233
Device Name Galaxy UNYCO System
Indications for Use (Describe)
The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
Temporary stabilization of the tibia and foot in conditions and procedures, such as:
- · comminuted open or closed tibial fractures
- · polytrauma patient
- · damage control orthopedics for fractures with severe soft tissue injuries
- peri-prosthetic or peri-implant fractures
- · joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
- · intra-operative fracture reduction
- · intermediate stabilization in staged surgery
- · infected non-union pending second stage treatment bone-loss or other reconstructive procedures
The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws. Galaxy Fixation System and bicortical screws must be used when Galaxy UNYCO is not indicated or available. The product is indicated for non-weight-bearing use.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/2 description: The image shows the logo for Orthofix, followed by the text "510(k) Summary". The Orthofix logo is a blue, abstract shape. The text is in a sans-serif font and is black.
(as required by 21 CFR 807.92)
| Submitter | Orthofix Srl |
|---|---|
| Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy | |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| Contact Person | Gianluca Ricadona
Quality & Regulatory Affairs Manager |
|----------------|-----------------------------------------------------------|
| Address | Via delle Nazioni, 9
37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| email | GianlucaRicadona@orthofix.it |
| Date Prepared | November 6, 2015 |
| Trade Name | Galaxy UNYCO System |
|---|---|
| Common Name | External Fixation Device and Accessories |
| Panel Code | Orthopedic |
| Classification | |
| Name | Single/multiple component metallic bone fixation appliances and |
| accessories. | |
| Class | Class II |
| Regulation | |
| Number | 21 CFR 888.3030 |
| Product Code | KTT |
| Predicate Device Name | 510(k) Number | Manufacturer |
|---|---|---|
| Synthes Large External Fixation, MR Conditional | K082650 | Synthes |
| Orthofix Galaxy Unyco Diaphyseal Tibia Kit | K142052 | Orthofix Srl |
| Description | The Orthofix Galaxy UNYCO System consists of a series of sterile kits that
include UNYCO Cancellous Screws, Large Multiscrew Clamps for
UNYCO Screws, Rods Ø 12mm, a radiolucent Foot Unit and specific
application tools. External fixation systems are modular, therefore different
frame configurations are possible. The Orthofix components in the Galaxy
UNYCO System are not intended to replace normal healthy bone or to
withstand the stresses of weight bearing. |
| ------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Indications and
Intended Use | The Galaxy UNYCO System is intended to be used for temporary bone
stabilization in trauma and orthopedic procedures of the lower limb prior
to definitive treatment.
Temporary stabilization of the tibia and foot in conditions and procedures,
such as:
• comminuted open or closed tibial fractures
• polytrauma patient
• damage control orthopedics for fractures with severe soft tissue injuries
• peri-prosthetic or peri-implant fractures
• joint dislocations, intra- and extra-articular injuries where spanning
fixation is needed |
| --------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
Traditional 510(k) Premarket Notification
Galaxy Unyco System
| • intra-operative fracture reduction |
|---|
| • intermediate stabilization in staged surgery |
| • infected non-union pending second stage treatment bone-loss or other |
| reconstructive procedures |
| The Galaxy UNYCO System is compatible with Galaxy Fixation System |
| and bicortical screws. Galaxy Fixation System and bicortical screws must |
| be used when Galaxy UNYCO is not indicated or available. |
| The product is indicated for non-weight-bearing use. |
| Technological
Characteristics
and Substantial
Equivalence | Documentation was provided to demonstrate that the Galaxy Unyco
System is substantially equivalent to the legally marketed predicates. The
devices and accessories included in the Galaxy Unyco System and the
predicate devices are all external fracture fixation systems as defined in
21 CFR 888.3030. The Galaxy Unyco System is substantially equivalent
to the predicate devices in intended use, site of application, patient
population, conditions-of-use, mechanical performances, basic design,
operating principles, and materials. The Galaxy Unyco System is
comparable to its predicate in size and materials. Testing in accordance
with ASTM F 1541-02 shows the mechanical strength of the subject device
to be equivalent or better than the predicate devices. |
| -------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Performance Data | The potential hazards have been evaluated and controlled through a Risk
Management Plan.
All testing met or exceeded the requirements as established by the test
protocols and applicable standards. A review of the mechanical data
indicates that the components of the Subject device are capable of
withstanding expected loads without failure. The Subject device was
therefore found to be substantially equivalent to the predicate devices.
Clinical data was not needed to support the safety and effectiveness of
the Subject Device.
The following mechanical testing was performed:
ASTM F 1541 "Standard Specification and Test Methods for External
Skeletal Fixation Devices" MRI compatibility testing was also conducted per: ASTM F2182 "Standard test method for measurement of radio
frequency induced heating near passive implants during magnetic
resonance imaging" |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on design, materials, intended use, technological characteristics,
and comparison to predicate devices, the Galaxy UNYCO System has
been shown to be substantially equivalent to legally marketed predicate
devices.. |