(174 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical implantation, with no mention of AI or ML technologies.
Yes.
The device is intended for gradually correcting angular growth deformities in growing children, which is a therapeutic intervention.
No
The device is an implantable system designed for correcting angular growth deformities in children by redirecting bone growth. It is a therapeutic device, not one that diagnoses conditions.
No
The device description explicitly details physical components like plates and screws, which are hardware implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "redirect the growth of long bones" and "gradually correct angular growth deformities in growing children." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a system of plates and screws implanted onto the bone. This is a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, tissue, etc.) or provide diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The Guided Growth Plate System Plus is intended for redirecting the growth of long bones.
It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus, or plantar flexion deformities of the ankle; valgus or varus deformities of the elbow (humerus), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
Product codes (comma separated list FDA assigned to the subject device)
OBT
Device Description
The Guided Growth Plate System Plus is designed for the gradual correction of pediatric congenital as well as acquired deformities in both the upper and lower extremities, provided that the physis (growth plates) are not fused.
It consists of different sizes of eight-Plate and quad-Plate plus with different cannulated and solid screw options.
The plates feature a contoured waist and low profile for pediatric usage.
There is a center hole in the plates for a temporary guide pin to be implanted, in order to aid application and removal of the plate.
The plates are attached to the external surface of the bone by screws, which are not locked to the plate but rather they are allowed to swivel and diverge in their position as bone growth occurs. The implant acts like a flexible hinge, permitting growth at the growth plate to gradually straighten the limb.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, knee (femur and/or tibia), ankle, elbow (humerus), wrist (radius).
Indicated Patient Age Range
Growing children
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
All testing met or exceeded the requirements, as established by the test protocols and applicable standard.
A review of the mechanical data indicates that the components of the Subject device continues to be capable of withstanding expected loads without failure.
The Subject device was therefore found to be substantially equivalent to the Predicate device and has the mechanical properties to perform its indications safely.
Clinical data was not needed to support the safety and effectiveness of the Subject Device.
The following standard has been followed to perform mechanical test on the System configuration:
• ASTM F564 – 10 "Standard Specification and Test Methods for Metallic Bone Staples".
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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 9, 2018
Orthofix Srl Gianluca Ricadona Sr. Quality & Regulatory Affairs Manager Via delle Nazioni. 9 97012 Bussolengo (VR) – Italy
Re: K172183
Trade/Device Name: Guided Growth Plate System Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: OBT Dated: November 27, 2017 Received: November 29, 2017
Dear Gianluca Ricadona:
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 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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Guided Growth Plate System Plus
Indications for Use (Describe)
The Guided Growth Plate System Plus is intended for redirecting the growth of long bones.
It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus, or plantar flexion deformities of the ankle; valgus or varus deformities of the elbow (humerus), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
| ☑ 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
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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Type of Use (Select one or both, as applicable)
3
510(k) Summary
(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 |
|---|---|
| Sr. 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.it |
07/14/2017 Date Prepared
| Trade Name | Guided Growth Plate System Plus |
|---|---|
| Common Name | Bone plate |
| Panel Code | 87 / Orthopaedic |
| Classification Name | plate, bone, growth control, pediatric, epiphysiodesis |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | OBT |
| Name of Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Guided Growth System Quad-Plate | K093442 | Orthofix Srl |
| Description | The Guided Growth Plate System Plus is designed for the gradual
correction of pediatric congenital as well as acquired deformities in both
the upper and lower extremities, provided that the physis (growth plates)
are not fused.
It consists of different sizes of eight-Plate and quad-Plate plus with
different cannulated and solid screw options.
The plates feature a contoured waist and low profile for pediatric usage.
There is a center hole in the plates for a temporary guide pin to be
implanted, in order to aid application and removal of the plate.
The plates are attached to the external surface of the bone by screws,
which are not locked to the plate but rather they are allowed to swivel and
diverge in their position as bone growth occurs. The implant acts like a
flexible hinge, permitting growth at the growth plate to gradually straighten
the limb. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for | The Guided Growth Plate System Plus is intended for redirecting the |
| Indications for
Use | The Guided Growth Plate System Plus is intended for redirecting the
growth of long bones. It is indicated for gradually correcting angular
growth deformities in growing children.
Specific conditions/diseases for which the device will be indicated include:
valgus, varus or flexion, extension deformities of the knee (femur and/or
tibia); valgus, varus, or plantar
flexion deformities of the ankle; valgus or varus deformities of the elbow
(humerus), and radial or ulnar deviation, flexion or extension deformities
of the wrist (radius). |
4
| Technological
Characteristics
and Substantial
Equivalence | Documentation was provided to demonstrate that the Subject device is
substantially equivalent to the predicate Guided Growth System Quad-
Plate (K093442) in the following fundamental aspects:
intended use, indications for use, site of application, patient population,
condition of use, technological characteristics, materials, mechanical
performances and implantable components.
Respect to the predicate, the Subject device provides design
improvements and additional dimensions for implantable components,
new sterile components and new related packaging configuration. |
| -------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| 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 standard. |
| | A review of the mechanical data indicates that the components of the
Subject device continues to be capable of withstanding expected loads
without failure. |
| | The Subject device was therefore found to be substantially equivalent to
the Predicate device and has the mechanical properties to perform its
indications safely. |
| | Clinical data was not needed to support the safety and effectiveness of
the Subject Device. |
| | The following standard has been followed to perform mechanical test on
the System configuration:
• ASTM F564 – 10 "Standard Specification and Test Methods for
Metallic Bone Staples". |
| Biocompatibility
data | In order to establish the Subject device non-pyrogenicity, some tests were
performed on an equivalent System devices, according to the following
international standard:
• USP 38: 2014 "Bacterial endotoxin test (LAL)".
• USP 38: 2014 "Medical devices – bacterial endotoxin and
pyrogen tests".
• ANSI / AAMI ST72: 2011 "Bacterial endotoxins - Test methodologies,
routine monitoring and alternative batch testing".
• FDA 2012 Q&A "Guidance for Industry Pyrogen and Endotoxins Testing:
Question and Answers". |
| | Here below the tests reports and rationale references list:
• 8 Plate Plus_QE_RA01_r1, test rationale
• Orthofix Biological Evaluation report, dated 2015/05/11
• 16VA00534 validation report, dated 2015/05/11 |
| Conclusion | Based upon similarities in: intended use, indications for use, site of |
| Conclusion | Based upon similarities in: intended use, indications for use, site of application, patient population, condition of use, technological characteristics, materials, mechanical performances, technology, materials and implantable components, Guided Growth Plate System Plus has been shown to be substantially equivalent to the legally marketed predicate device and to be safe and effective for its intended use. |
|---|---|
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |