(112 days)
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.
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.
The subject device implants, bone plates and bone screws, 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)".
Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments and accessories offered by Orthofix are classified as class I devices exempt from 510(k), under the product code LXH, according to 21 CFR 888.4540 Orthopedic Manual Surgical Instrument, and product code FSM according to 21 CFR 878.4800 Manual surgical instrument for general use.
These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 420B, AISI 303, X15TN), Aluminum alloy (EN-AW 6082 T6), and plastic material (PP-H PROPILUX).
JPS JuniOrtho Plating System™ is designed to be used in the operating theatre only.
This is a medical device 510(k) summary, not a study report for an AI/ML powered device. As such, it does not contain any information about:
- Acceptance criteria and reported device performance for an AI/ML algorithm.
- Sample sizes or data provenance for a test set.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This document describes a traditional medical device, the "JPS JuniOrtho Plating System™," which consists of physical plates and screws for internal fixation of bones. The performance analysis mentioned refers to bench testing and engineering assessments of the mechanical properties of the hardware, compared to predicate devices, to demonstrate substantial equivalence.
Therefore, I cannot provide the requested table and information based on the provided text.
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May 22, 2020
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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.
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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 (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 (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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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)
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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 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 submission | May 22, 2020 |
Trade Name, Common Name, Classification
| Trade Name | JPS JuniOrtho Plating System™ |
|---|---|
| Common name | Plating system |
| Device | Plate, fixation, boneScrew, fixation, bone |
| Product code | HRSHWC |
| Panel Code | Orthopedic |
| Classification | Class II |
| Regulation Number | 21 CFR 888.303021 CFR 888.3040 |
Predicate devices and reference devices
| Predicate Device | 510(k)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 PlateSystem | K083286 | Orthopediatrics, Corp. |
| Orthofix External Fixation Screw (Pin) WithHydroxyapatite 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. |
|---|---|
| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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| The subject device implants, bone plates and bone screws, aremade from Stainless steel AISI 316LVM, according to ASTMF138 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire forSurgical Implants (UNS S31673)".Surgical procedures with the use of the subject implants maybe performed with the support of general orthopedicinstrumentation, to facilitate their proper insertion and removalfrom the patient. The instruments and accessories offered byOrthofix are classified as class I devices exempt from 510(k),under the product code LXH, according to 21 CFR 888.4540Orthopedic Manual Surgical Instrument, and product codeFSM according to 21 CFR 878.4800 Manual surgicalinstrument for general use.These instruments are made by medical grade stainless steel(AISI 316LVM, AISI 630, AISI 420B, AISI 303, X15TN),Aluminum alloy (EN-AW 6082 T6), and plastic material (PP-HPROPILUX).JPS JuniOrtho Plating System™ is designed to be used in theoperating theatre only. | |
|---|---|
| Indications for use | The JPS JuniOrtho Plating System™ is intended for internalfixation and stabilization of fractures, osteotomies, mal-unionsand non-unions of long bones of the lower limb.The JPS JuniOrtho Plating System™ is indicated for internalfixation 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 System™ is indicated inpediatric (excluding newborns) and small stature adultpatients. |
| TechnologicalCharacteristics andIntended Use | The subject device fundamental scientific principles andtechnological characteristic, including: the intended use,material and general design, are the same as, or similar to, thechosen predicate devices.Summary of the technological characteristics and IntendedUse:✓ Intended use: identical.✓ Indications for Use, Anatomical sites, operating principlesand conditions of use: are substantially equivalent topredicates; no new risks associated to the subject devicewith combined indications for use compared to those of thepredicates which have definite indications for use foranatomical site, having demonstrated substantiallyequivalent safety and effectiveness to the anatomical sitesspecific for each predicate device.✓ Material are equivalent (Stainless Steel);✓ Geometry and size: similar sizes and geometry of the boneplates; similar sizes and geometry of the bone screws.✓ Sterilization, same method as the two predicates.The technological characteristics of the JPS JuniOrtho PlatingSystem™ are substantially equivalent to the predicate devices. |
| PerformanceAnalysis | Subject device has similar configuration, material, sizes anddesign as the predicate devices.Bench testing and engineering assessments on worst cases ofsubject device and corresponding predicate devices, confirmthat subject devices have equivalent or better mechanicalperformances. Testing was done per consensus standards:ASTM F382-17, F384-17, F543-17, and F1264-16.Any potential hazards have been evaluated and controlledthrough Risk Management activities.The review of clinical literatures on similar devices still supportthe clinical data of the Subject devices with no additionalclinical information. |
| Conclusion | Based upon equivalences in: intended use, site of application,conditions of use, operating principles, and the non-clinicalperformance data, the JPS JuniOrtho Plating System™ hasbeen shown to be safe and effective, and performs as well asor better than the legally marketed predicate devices.Therefore, the Subject device is expected to be declaredsubstantially equivalent to the legally marketed predicatedevices. |
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§ 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.