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).

Device Description

The Subject new 3.5mm thread diameter screw is a gamma extension of the existing screws (thread Ø4.5mm), components of the predicate Guided Growth Plate System Plus (K172183). The Subject device is a 3.5mm thread diameter screw, available in three lengths and manufactured by the same material (Ti6Al4V), as the 4.5mm diameter gamma screws, included in the predicate Guided Growth Plate System Plus (K172183).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Guided Growth Plate System Plus" and a new 3.5mm thread diameter screw, which is an extension of the existing screws for the system. The submission focuses on demonstrating substantial equivalence to a predicate device (K172183) rather than proving the device meets acceptance criteria through a clinical study in the traditional sense of a diagnostic AI device.

Therefore, many of the requested categories for AI/diagnostic device studies are not directly applicable. However, I can extract the relevant information regarding performance testing and how substantial equivalence was demonstrated.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is for a new screw size, so the "performance" is in demonstrating that this new size is as safe and effective as the existing screws within the Guided Growth Plate System Plus. The acceptance criteria relate to mechanical testing standards.

Acceptance Criteria	Reported Device Performance
Mechanical Testing: Demonstrate mechanical integrity and safety of the 3.5mm thread diameter screw according to established standards.	Testing activities met the established acceptance criteria, demonstrating that the device does not introduce additional risks compared to the predicate device. Specific standards followed: ASTM F564-17, ASTM F1264-16, ASTM F543-17.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated regarding the number of screws or plates tested, but implies tests were conducted on the new 3.5mm thread diameter screws.
Data Provenance: The testing was mechanical, performed by the manufacturer, Orthofix Srl, in Italy. This is laboratory/bench testing, not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the "ground truth" for mechanical testing is adherence to engineering standards and robust physical properties, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable for mechanical testing. The results are quantitative measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a hardware device (bone plate system components), not an AI/diagnostic software, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a hardware device.

7. The Type of Ground Truth Used

Mechanical Testing Standards: The "ground truth" for the performance data in this submission is the fulfillment of established engineering and material standards (ASTM F564, ASTM F1264, ASTM F543) for bone fixation devices and screws.
Clinical Literature Analysis: Supported by analysis of clinical literature to demonstrate clinical equivalence between the plate and screw system and staples (the reference devices).

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a hardware device.

Additional Information from the document:

Device Description: The "Subject new 3.5mm thread diameter screw is a gamma extension of the existing screws (thread Ø4.5mm), components of the predicate Guided Growth Plate System Plus (K172183)." It is made of the same Ti6Al4V material.
Technological Characteristics & Substantial Equivalence: The submission claims substantial equivalence based on:
- Indications for use
- Intended patient population
- System composition
- Implant material
- Method of fixation
- Packaging configuration
- Sterilization method
- Biocompatibility
- MRI compatibility
- The only change is a design dimensional specification for the new 3.5mm thread diameter screw.
Biocompatibility Data: No additional assessment was required because the subject device is equivalent in material, manufacturing, sterilization, etc., to the predicate device (K172183).
Conclusion: The analysis of performance data (mechanical testing and clinical literature review) supports the conclusion that the new 3.5mm thread diameter screw is safe and effective and substantially equivalent to the predicate (K172183).

Summary

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May 15, 2018

Orthofix Srl Gianluca Ricadona Sr. Quality & Regulatory Affairs Manager Via delle Nazioni. 9 97012 Bussolengo (VR) Italy

Re: K180624

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: April 24, 2018 Received: April 25, 2018

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 (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K180624

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).

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)

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FORM FDA 3881 (8/14)

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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
email	GianlucaRicadona@orthofix.it
Preparation date	5/3/2018
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 Plate System Plus	K172183	Orthofix Srl
Fixation staples	K834513	STRYKER CORP.
- Blount Staple Epiphyseal(Reference device)
Pediloc Fragment System	K140431	OrthoPediatrics Corp
Description	The Subject new 3.5mm thread diameter screw is agamma extension of the existing screws (threadØ4.5mm), components of the predicate GuidedGrowth Plate System Plus (K172183).The Subject device is a 3.5mm thread diameter screw,available in three lengths and manufactured by thesame material (Ti6Al4V), as the 4.5mm diametergamma screws, included in the predicate GuidedGrowth Plate System Plus (K172183).
Indications for use	The Guided Growth Plate System Plus is intended forredirecting the growth of long bones.It is indicated for gradually correcting angular growthdeformities in growing children. Specificconditions/diseases for which the device will beindicated include: valgus, varus or flexion, extensiondeformities of the knee (femur and/ortibia); valgus, varus, or plantar flexion deformities ofthe ankle; valgus or varus deformities of the elbow(humerus), and radial or ulnar deviation, flexion orextension deformities of the wrist (radius).
Technological Characteristics andSubstantial Equivalence	Documentation was provided to demonstrate that theSubject device is substantially equivalent to the
	(K172183) component(s), in the following fundamental aspects:indications for use, intended patient population, system composition, implant material, method offixation, packaging configuration, sterilization method, biocompatibility and MRI compatibility.Respect to the predicate (K172183), the Subject device is a design dimensional specification change for
	the introduction of the new thread diameter 3.5mm screw.
Performance data	The design dimensional specification change of the Subject device has been managed by design control activity and Risk Management process. The potential identified risks have been measured and mitigated through mechanical testing and clinical literature analysis, in order to demonstrate that the Subject Device does not introduce additional risks respect to the predicate (K172183).
	The testing activity results demonstrated to meet the established acceptance criteria.The following standards have been followed to perform mechanical test on the Subject device:• ASTM F564 - 17 "Standard Specification and Test Methods for Metallic Bone Staples".• ASTM F1264 -16 "Standard Specifications and Test Methods for Intramedullary Fixation Devices".• ASTM F543 - 17 "Standard Specification and Test Methods for Metallic Medical Bone Screws".
	The functional mechanical testing results are supported by the clinical literature analysis, conducted to demonstrate the clinical equivalence between the two alternative clinical procedure by:- using the plate and screw system "Guided Growth plate" K031493 - master Orthofix System for pediatric growth control and epiphysiodesis treatment),- using the staples, chosen as reference devices for the performance data.
Biocompatibility data	The Subject device is equivalent in its final finished form to the predicate device, Guided Growth Plate System Plus (K172183), concerning the:manufacturing, sterilization, processing, geometry, material, intended population, anatomical location and duration of exposure.Therefore, no additional biocompatibility assessment
	was required for the Subject device.
Conclusion	The analysis on the performance data within this Premarket Notification supports the conclusion that the new Subject gamma size 3.5mm thread diameter screw is safe and effective as the predicate (K172183).

510(k) Summary

Suired by 21 CER 807

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Regulation Number and Section

§ 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.