JPS JuniOrtho Plating System

K200246 · Orthofix Srl · HRS · May 22, 2020 · Orthopedic

Device Facts

• Record ID: K200246
• Device Name: JPS JuniOrtho Plating System
• Applicant: Orthofix Srl
• Product Code: HRS · Orthopedic
• Decision Date: May 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, mal-unions 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 stature adult patients.

Device Story

JPS JuniOrtho Plating System consists of metallic bone plates and screws for internal fixation and stabilization of long bone fractures, osteotomies, mal-unions, and non-unions. Used in operating theaters by surgeons; implants provide mechanical support to bone segments during healing. System includes various plate sizes/shapes and locking/cortical screws designed for femoral and tibial anatomy. Implants are provided sterile or non-sterile. Device benefits patients by facilitating bone alignment and stabilization in pediatric and small-stature adult populations.

Clinical Evidence

No clinical data; bench testing only. Mechanical performance evaluated via testing per ASTM F382-17, F384-17, F543-17, and F1264-16. Clinical literature review on similar devices supports safety and effectiveness.

Technological Characteristics

Implants made of Stainless steel AISI 316LVM (ASTM F138). System includes bone plates and locking/cortical screws. Mechanical fixation principle. Instruments made of stainless steel (AISI 316LVM, 630, 420B, 303, X15TN), Aluminum alloy (EN-AW 6082 T6), and plastic (PP-H PROPILUX).

Indications for Use

Indicated for internal fixation and stabilization of fractures, osteotomies, mal-unions, and non-unions of lower limb long bones (femur and tibia) in pediatric patients (excluding newborns) and small stature adults.

Regulatory Classification

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.

Predicate Devices

• Synthes Lcp Pediatric Plates (K112085)
• Orthopediatrics Pediloc™ Tibial Plate System (K100240)

Reference Devices

• Orthopediatrics Pediloc™ Locking Plate System (K083286)
• Orthofix External Fixation Screw (Pin) With Hydroxyapatite Coating (K974186)
• Orthofix Titanium Nailing Systems (K053261)

Submission Summary (Full Text)

{0}------------------------------------------------

May 22, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 24408

Re: K200246

Trade/Device Name: JPS JuniOrtho Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 31, 2020 Received: January 31, 2020

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.

{1}------------------------------------------------

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 (OS) 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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K200246

Device Name

JPS JuniOrtho Plating System™

Indications for Use (Describe)

The JPS JuniOrtho Plating System™ is internal fixation and stabilization of fractures, osteotomies, mal-unions 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 stature adult patients.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *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 [e-mail]

"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/1 description: The image shows the Orthofix logo, which includes a blue abstract shape above the word "ORTHOFIX" in bold, black letters. Below the logo, the text "510(k) Summary" is displayed in a larger, bold font. Underneath that, the text "(21 CFR 807.92)" is shown in a smaller font, indicating the regulatory reference for the summary.

## 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 Ricadona<br>Sr. Quality & Regulatory Affairs Manager |
|--------------------|---------------------------------------------------------------|
| Address | Via delle Nazioni, 9<br>37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719 000 |
| Fax | + 39 045 6719 380 |
| Email address | [e-mail] |
| Date of submission | May 22, 2020 |

# Trade Name, Common Name, Classification

| Trade Name | JPS JuniOrtho Plating System™ |
|-------------------|------------------------------------------------|
| Common name | Plating system |
| Device | Plate, fixation, bone<br>Screw, fixation, bone |
| Product code | HRS<br>HWC |
| Panel Code | Orthopedic |
| Classification | Class II |
| Regulation Number | 21 CFR 888.3030<br>21 CFR 888.3040 |

## Predicate devices and reference devices

| Predicate Device | 510(k)<br>Number | Manufacturer |
|-----------------------------------------------------------------------|------------------|----------------------------|
| Primary Predicate | | |
| Synthes Lcp Pediatric Plates | K112085 | Synthes (Usa) Products LLC |
| Additional Predicate | | |
| Orthopediatrics Pediloc™ Tibial Plate System | K100240 | Orthopediatrics, Corp. |
| Reference Device | | |
| Orthopediatrics Pediloc™ Locking Plate<br>System | K083286 | Orthopediatrics, Corp. |
| Orthofix External Fixation Screw (Pin) With<br>Hydroxyapatite Coating | K974186 | Orthofix Srl |
| Orthofix Titanium Nailing Systems | K053261 | Orthofix Srl |

| Device description | The JPS JuniOrtho Plating System™ consists of plate's sizes and shapes ranges, designed to accept locking and cortical bone screws, which are available in a variety of diameters and lengths, in order to support internal fixation and stabilization of fractures, osteotomies, mal-unions and non-unions in long bones of lower limbs. The JPS JuniOrtho Plating System™ is designed according to the anatomic region of clinical application: femur and tibia. The implants would be offered both in sterile and non-sterile packaging configurations. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

{4}------------------------------------------------

| | The subject device implants, bone plates and bone screws, are<br>made from Stainless steel AISI 316LVM, according to ASTM<br>F138 "Standard Specification for Wrought 18Chromium-<br>14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for<br>Surgical Implants (UNS S31673)".<br>Surgical procedures with the use of the subject implants may<br>be performed with the support of general orthopedic<br>instrumentation, to facilitate their proper insertion and removal<br>from the patient. The instruments and accessories offered by<br>Orthofix are classified as class I devices exempt from 510(k),<br>under the product code LXH, according to 21 CFR 888.4540<br>Orthopedic Manual Surgical Instrument, and product code<br>FSM according to 21 CFR 878.4800 Manual surgical<br>instrument for general use.<br>These instruments are made by medical grade stainless steel<br>(AISI 316LVM, AISI 630, AISI 420B, AISI 303, X15TN),<br>Aluminum alloy (EN-AW 6082 T6), and plastic material (PP-H<br>PROPILUX).<br>JPS JuniOrtho Plating System™ is designed to be used in the<br>operating theatre only. |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The JPS JuniOrtho Plating System™ is intended for internal<br>fixation and stabilization of fractures, osteotomies, mal-unions<br>and non-unions of long bones of the lower limb.<br>The JPS JuniOrtho Plating System™ is indicated for internal<br>fixation and stabilization of femoral and tibial fractures,<br>osteotomies, mal-unions and non-unions.<br>Indications include:<br>- Varus, valgus, rotational and/or shortening osteotomies<br>- Femoral neck and/or pertrochanteric fractures<br>- Proximal and distal metaphyseal fractures<br>- Pathological and impeding pathological fractures<br>Use of the JPS JuniOrtho Plating System™ is indicated in<br>pediatric (excluding newborns) and small stature adult<br>patients. |
| Technological<br>Characteristics and<br>Intended Use | The subject device fundamental scientific principles and<br>technological characteristic, including: the intended use,<br>material and general design, are the same as, or similar to, the<br>chosen predicate devices.<br>Summary of the technological characteristics and Intended<br>Use:<br>✓ Intended use: identical.<br>✓ Indications for Use, Anatomical sites, operating principles<br>and conditions of use: are substantially equivalent to<br>predicates; no new risks associated to the subject device<br>with combined indications for use compared to those of the<br>predicates which have definite indications for use for<br>anatomical site, having demonstrated substantially<br>equivalent safety and effectiveness to the anatomical sites<br>specific for each predicate device.<br>✓ Material are equivalent (Stainless Steel);<br>✓ Geometry and size: similar sizes and geometry of the bone<br>plates; similar sizes and geometry of the bone screws.<br>✓ Sterilization, same method as the two predicates.<br>The technological characteristics of the JPS JuniOrtho Plating<br>System™ are substantially equivalent to the predicate devices. |
| Performance<br>Analysis | Subject device has similar configuration, material, sizes and<br>design as the predicate devices.<br>Bench testing and engineering assessments on worst cases of<br>subject device and corresponding predicate devices, confirm<br>that subject devices have equivalent or better mechanical<br>performances. Testing was done per consensus standards:<br>ASTM F382-17, F384-17, F543-17, and F1264-16.<br>Any potential hazards have been evaluated and controlled<br>through Risk Management activities.<br>The review of clinical literatures on similar devices still support<br>the clinical data of the Subject devices with no additional<br>clinical information. |
| Conclusion | Based upon equivalences in: intended use, site of application,<br>conditions of use, operating principles, and the non-clinical<br>performance data, the JPS JuniOrtho Plating System™ has<br>been shown to be safe and effective, and performs as well as<br>or better than the legally marketed predicate devices.<br>Therefore, the Subject device is expected to be declared<br>substantially equivalent to the legally marketed predicate<br>devices. |

{5}------------------------------------------------