The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, malunions and non-unions of long bones of the lower limb.

The JPS JuniOrtho Plating System™ is indicated for internal fixation of femoral and tibial fractures, osteotomies, mal-unions and non-unions.

Indications include:

Varus, valgus, rotational and/or shortening osteotomies
Femoral neck and/or pertrochanteric fractures
Proximal and distal metaphyseal fractures
Pathological and impeding pathological fractures

Use of the JPS JuniOrtho Plating System™ is indicated in pediatric (excluding newborns) and small statients.

Device Description

The Subject Device is a line extension of the existing locking and non- locking screws with same indications and intended use, diameters and new lengths, and with a modified geometry, to be used in addition to those already cleared for use (JPS JuniOrtho Plating System K200246).
The predicate device, screws are offered both in sterile and non-sterile packaging configurations and are made from Stainless steel AISI 316LVM, according to ASTM F138 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".

AI/ML Overview

This is a medical device submission (510k) for a bone fixation system, not an AI/ML device. Therefore, the requested information about acceptance criteria and study details related to AI/ML device performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable to this document.

The document discusses the substantial equivalence of the JPS JuniOrtho Plating System™ (a line extension) to a predicate device, focusing on mechanical performance, biocompatibility, and intended use.

Here's the relevant information provided:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical Testing: Demonstrate that the Subject Device does not introduce additional risks compared to the predicate (K200246) based on identified potential risks.	"The testing activity results demonstrated to meet the established acceptance criteria." The testing was performed following ASTM F543 – 17 "Standard Specification and Test Methods for Metallic Medical Bone Screws".

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as this is a medical device (bone fixation system) and not an AI/ML device. The "test set" refers to mechanical testing of the physical device components. Specific sample sizes for the mechanical tests are not detailed in this summary, but are typically defined by the ASTM standard or internal protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses. For a physical medical device, "ground truth" relates to engineering specifications and performance standards which are met through physical testing and quality control processes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are relevant to devices that assist human interpretation, particularly in diagnostic imaging or clinical decision support AI/ML tools.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This pertains to AI/ML algorithm performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable as an AI/ML ground truth. For this device, the "ground truth" for its performance is defined by adherence to established mechanical standards (e.g., ASTM F543 – 17) and engineering specifications, ensuring safety and efficacy consistent with its intended use and predicate device.

8. The sample size for the training set

Not applicable. Training sets are used for AI/ML model development.

9. How the ground truth for the training set was established

Not applicable. This relates to AI/ML model development.

Summary

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January 18, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLG PO Box 15729 Wilmington, North Carolina 28408

Re: K213572

Trade/Device Name: JuniOrtho Plating System™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 8, 2021 Received: November 10, 2021

Dear Cheryl 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K213572

Device Name JuniOrtho Plating System™

Indications for Use (Describe)

The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, malunions and non-unions of long bones of the lower limb.

The JPS JuniOrtho Plating System™ is indicated for internal fixation of femoral and tibial fractures, osteotomies, mal-unions and non-unions.

Indications include:

Varus, valgus, rotational and/or shortening osteotomies
Femoral neck and/or pertrochanteric fractures
Proximal and distal metaphyseal fractures
Pathological and impeding pathological fractures

Use of the JPS JuniOrtho Plating System™ is indicated in pediatric (excluding newborns) and small statients.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image shows the Orthofix logo, which is a stylized blue shape above the word "ORTHOFIX" in black, bold letters. Below the logo, the text "510(k) Summary for K213572" is written in a smaller, black font. The text indicates that the document is a summary related to a 510(k) premarket submission with the reference number K213572.

(21 CFR 807.92)

Submitter information
Submitter Name	Orthofix Srl
Address	Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719.000
Fax	+ 39 045 6719.380

Contact Person	Gianluca RicadonaSr. Quality & Regulatory Affairs Manager
Address	Via delle Nazioni, 937012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719 000
Fax	+ 39 045 6719 380
Email address	GianlucaRicadona@orthofix.it
Date of summary	January 18, 2022

Trade Name, Common Name, Classification

Trade Name	JPS JuniOrtho Plating System™
Device	Screw, fixation, bone
Product code	HWC
Panel Code	Orthopedic
Class	Class II
Classification RegulationNumber	21 CFR 888.3040

Predicate devices

Primary Predicate Device	510(k)Number	Manufacturer
JPS JuniOrtho Plating System™	K200246	Orthofix Srl
Other Predicate Devices
Synthes Lcp Pediatric Plates	K112085	Synthes (USA) Products LLC

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Traditional 510(k) Premarket Notification JuniOrtho Plating System™ - Line extension

Orthopediatrics Pediloc™ Tibial Plate System	K100240	Orthopediatrics, Corp.
----------------------------------------------	---------	------------------------

Device description	The Subject Device is a line extension of the existing locking and non- locking screws with same indications and intended use, diameters and new lengths, and with a modified geometry, to be used in addition to those already cleared for use (JPS JuniOrtho Plating System K200246).The predicate device, screws are offered both in sterile and non-sterile packaging configurations and are made from Stainless steel AISI 316LVM, according to ASTM F138 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)".
Indications for use	Being a Line Extension, the Indications for use of the Subject device are identical to the predicate's JPS JuniOrtho Plating SystemTM and are referred to the whole system as follows.JPS JuniOrtho Plating SystemTM is intended for internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions of long bones of the lower limb.The JPS JuniOrtho Plating SystemTM is indicated for internal fixation and stabilization of femoral and tibial fractures, osteotomies, mal- unions and non-unions.Indications include:- Varus, valgus, rotational and/or shortening osteotomies- Femoral neck and/or pertrochanteric fractures- Proximal and distal metaphyseal fractures- Pathological and impeding pathological fracturesUse of the JPS JuniOrtho Plating SystemTM is indicated in pediatric (excluding newborns) and small stature adult patients.
TechnologicalCharacteristics andIntended Use	Documentation was provided to demonstrate that the Subject device is substantially equivalent to the predicate JPS JuniOrtho Plating System (K200246) component(s), in the following fundamental aspects:Intended use, indications for use, intended population, sites of application, operating principles and method of fixation, material, conditions of use, mechanical performances, basic design, packaging configuration, sterilization method, biocompatibility and MRI compatibility.
Performance Data	The design dimensional specification change of the Subject device hasbeen managed by design control activity and Risk Managementprocess. The potential identified risks have been measured andmitigated through mechanical testing, in order to demonstrate that theSubject Device does not introduce additional risks respect to thepredicate (K200246).The testing activity results demonstrated to meet the establishedacceptance criteria.The following standards have been followed to perform mechanical teston the Subject device:ASTM F543 – 17 "Standard Specification and Test Methods for MetallicMedical Bone Screws".
Biocompatibilitydata	The Subject device is equivalent in its final finished form of the predicatedevice, JPS JuniOrtho Plating System (K200246), concerning the:manufacturing, sterilization, processing, material, intended population,anatomical location and duration of exposure.Therefore, no additional biocompatibility assessment was required forthe Subject device.
Conclusion	The analysis on the performance data within this Premarket Notificationsupports the conclusion that the new Subject device is substantiallyequivalent to the predicate (K200246).

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.