(69 days)
Not Found
No
The summary describes a mechanical plating system and does not mention any software, algorithms, or AI/ML capabilities.
Yes, this device is a therapeutic device.
Explanation: The device is designed for internal fixation and stabilization of fractures, osteotomies, malunions, and non-unions of long bones, which are all treatments aimed at alleviating or improving a medical condition.
No
Explanation: The device is an internal fixation system used for treating fractures and osteotomies, not for diagnosing medical conditions.
No
The device description explicitly states it is a line extension of existing locking and non-locking screws made from Stainless steel, indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes the JPS JuniOrtho Plating System as an internal fixation and stabilization system for bones. It is a physical implant used to treat fractures, osteotomies, malunions, and non-unions.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status. Its function is purely mechanical and therapeutic.
Therefore, based on the provided information, the JPS JuniOrtho Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
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)".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones of the lower limb, femoral, tibial
Indicated Patient Age Range
pediatric (excluding newborns) and small stature adult patients.
Intended User / Care Setting
Not Found
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)
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, in order to demonstrate that the Subject Device does not introduce additional risks respect to the predicate (K200246).
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 F543 – 17 "Standard Specification and Test Methods for Metallic Medical Bone Screws".
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
§ 888.3040 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.
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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.
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 (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)
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 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 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 Regulation | |
| Number | 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 fractures
Use of the JPS JuniOrtho Plating SystemTM is indicated in pediatric (excluding newborns) and small stature adult patients. |
| Technological
Characteristics and
Intended 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 has
been managed by design control activity and Risk Management
process. The potential identified risks have been measured and
mitigated through mechanical testing, in order to demonstrate that the
Subject Device does not introduce additional risks respect to the
predicate (K200246).
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 F543 – 17 "Standard Specification and Test Methods for Metallic
Medical Bone Screws". |
| Biocompatibility
data | The Subject device is equivalent in its final finished form of the predicate
device, 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 for
the Subject device. |
| Conclusion | The analysis on the performance data within this Premarket Notification
supports the conclusion that the new Subject device is substantially
equivalent to the predicate (K200246). |
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