(130 days)
Not Found
No
The device description and performance studies focus on mechanical properties and standard external fixation components, with no mention of AI or ML.
Yes
The device is described as providing "treatment for bone stabilization in trauma, specifically lower limb fractures that require temporary fixation prior to definitive fixation," which directly aligns with the definition of a therapeutic device.
No
Explanation: The device is described as an external fixation system intended for temporary stabilization of bone fractures (treatment), not for diagnosing conditions.
No
The device description explicitly lists physical components such as screws, clamps, and rods, which are hardware. The intended use also describes a physical external fixation system for bone stabilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide temporary mechanical stabilization for bone fractures in the lower limb. This is a surgical/mechanical intervention, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The device consists of screws, clamps, rods, and tools used for external fixation. These are physical components designed to hold bones in place.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status based on such analysis.
The device is clearly a surgical implant/external fixation system used for treating bone fractures.
N/A
Intended Use / Indications for Use
The Galaxy UNYCO Diaphyseal Tibia Kit is intended to be used to provide treatment for bone stabilization in trauma, specifically lower limb fractures that require temporary fixation prior to definitive fixation.
The Galaxy UNYCO Diaphyseal Tibia Kit is indicated to be used for temporary stabilization of tibial fractures in trauma procedures (damage control orthopaedics prior to definitive treatment). The product is indicated for non-weight- bearing use. The indications for use include:
• Tibial fractures extending from about 8cm below the knee to about 7 cm above the ankle joint, including comminuted open or closed tibial fractures and polytrauma.
• Temporary stabilisation of the tibia after debridement for osteomyelitis or an infected non-union pending second stage treatment.
Product codes
KTT
Device Description
The Orthofix Galaxy UNYCO Diaphyseal Tibia Kit consists of a series of UNYCO Screws, UNYCO Cancellous Screws, Large Multiscrew Clamp for UNYCO Screws, Rods Ø12mm L 350mm and specific application tools. External fixation systems are modular, therefore different frame configurations are possible. The Orthofix components in the Galaxy UNYCO Diaphyseal Tibia Kit are not intended to replace normal healthy bone or to withstand the stresses of weight bearing. The System is intended to be used to provide treatment for bone stabilization in trauma, specifically lower limb fractures that require temporary fixation prior to definitive fixation. The System may be used in conjunction with the Orthofix Galaxy Fixation system for crossing the knee and the ankle during temporary fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial, ankle joint, knee
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 Predicates. 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
Orthofix Srl % Ms. Cheryl Wagoner Principal Consultant Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408
Re: K142052
Trade/Device Name: Orthofix Galaxy UNYCO Diaphyseal Tibia Kit 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 3, 2014 Received: November 4, 2014
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.
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
510(k) Number (if known) K142052
Device Name Galaxy UNYCO Diaphyseal Tibia Kit
Indications for Use (Describe)
The Galaxy UNYCO Diaphyseal Tibia Kit is intended to be used to provide treatment for bone stabilization in trauma, specifically lower limb fractures that require temporary fixation prior to definitive fixation.
The Galaxy UNYCO Diaphyseal Tibia Kit is indicated to be used for temporary stabilization of tibial fractures in trauma procedures (damage control orthopaedics prior to definitive treatment). The product is indicated for non-weight- bearing use. The indications for use include:
• Tibial fractures extending from about 8cm below the knee to about 7 cm above the ankle joint, including comminuted open or closed tibial fractures and polytrauma.
· Temporary stabilisation of the tibia after debridement for osteomyelitis or an infected non-union pending second stage treatment.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Traditional 510(k) Premarket Notification Orthofix Galaxy ÚNYCO Diaphyseal Tibia Kit
Image /page/3/Picture/2 description: The image shows the logo for Orthofix, a medical device company. The logo consists of a stylized blue symbol above the word "ORTHOFIX" in bold, black letters. Below the logo is the text "510(k) Summary" in a smaller, black font. The image is likely from a document related to the company's products or regulatory submissions.
(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 |
| gianlucaricadona@orthofix.com | |
| Date Prepared | November 28th, 2014 |
| Trade Name | Orthofix Galaxy UNYCO Diaphyseal Tibia Kit |
|---|---|
| Common Name | External Fixation Device and Accessories |
| Panel Code | Orthopaedics/87 |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories. |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | KTT |
| Device Name | 510(k) Number | Manufacturer |
|---|---|---|
| Synthes Large External Fixation, MR Conditional | K082650 | Synthes |
| Orthofix Galaxy Fixation | K113770 | Orthofix Srl |
| Hoffmann 3 External Fixation System | K122284 | Stryker |
| Description | The Orthofix Galaxy UNYCO Diaphyseal Tibia Kit consists of a series of
UNYCO Screws, UNYCO Cancellous Screws, Large Multiscrew Clamp for
UNYCO Screws, Rods Ø12mm L 350mm and specific application tools.
External fixation systems are modular, therefore different frame
configurations are possible. The Orthofix components in the Galaxy
UNYCO Diaphyseal Tibia Kit are not intended to replace normal healthy
bone or to withstand the stresses of weight bearing. The System is
intended to be used to provide treatment for bone stabilization in trauma,
specifically lower limb fractures that require temporary fixation prior to
definitive fixation. The System may be used in conjunction with the
Orthofix Galaxy Fixation system for crossing the knee and the ankle
during temporary fixation. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications and | The Galaxy UNYCO Diaphyseal Tibia Kit is intended to be used to provide |
| Indications and
Intended Use | The Galaxy UNYCO Diaphyseal Tibia Kit is intended to be used to provide
treatment for bone stabilization in trauma, specifically lower limb fractures
that require temporary fixation prior to definitive fixation. |
| | The Galaxy UNYCO Diaphyseal Tibia Kit is indicated to be used for |
4
Traditional 510(k) Premarket Notification
Orthofix Galaxy UNYCO Diaphyseal Tibia Kit
| temporary stabilization of tibial fractures in trauma procedures (damage
control orthopaedics prior to definitive treatment). The product is indicated
| for non-weight- bearing use. The indications for use include: |
|---|
| • Tibial fractures extending from about 8cm below the knee to about 7 cm |
| above the ankle joint, including comminuted open or closed tibial fractures |
| and polytrauma. |
| • Temporary stabilisation of the tibia after debridement for osteomyelitis or |
| an infected non union pending second stage treatment. |
| Technological
Characteristics
and Substantial
Equivalence | Documentation was provided to demonstrate that the Orthofix Galaxy
UNYCO Diaphyseal Tibia Kit is substantially equivalent to the legally
marketed Predicates. The devices and accessories included in the
Orthofix Galaxy UNYCO Diaphyseal Tibia Kit and the predicate devices
are all external fracture fixation systems as defined in 21 CFR 888.3030.
The Galaxy UNYCO Diaphyseal Tibia Kit 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 Diaphyseal Tibia Kit 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 at least equivalent to 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 Predicates. 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, |
| Conclusion | Based on design, materials, intended use, technological characteristics,
and comparison to predicate devices, the Subject Orthofix Galaxy
UNYCO Diaphyseal Tibia Kit has been shown to be substantially
equivalent to legally marketed predicate devices. |
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|