(41 days)
None
No
The 510(k) summary describes a line extension of orthopedic screws and does not mention any AI or ML components or functionalities.
No
This device is for temporary internal fixation and stabilization of long bone fractures, which is a supportive role in healing, rather than a treatment of a disease or condition. While it aids in the healing process, it doesn't therapeutically treat a condition itself.
No
Explanation: The device is intended for internal fixation and stabilization of bone fractures and osteotomies, which is a therapeutic function, not a diagnostic one. It is a surgical implant used to treat existing conditions rather than to identify or analyze them.
No
The device description explicitly states that the device is a system that combines implants (plates and screws) and instruments, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions". This describes a surgical implant used to treat physical conditions within the body.
- Device Description: The device is described as "implants (plates and screws) and instruments". These are physical devices used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided describes a surgical implant system, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The OrthoPediatrics Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.
Product codes
HRS, HWC
Device Description
The OrthoPediatrics Locking Proxurual Femur System Cortical Screws are a line extension to expand the current offering to allow for longer cortical screws. The screws are part of one system that combines implants (plates and screws) and instruments. The additional cortical screw sizes include the following: 55mm, 60mm, 65mm, 70mm, 75mm, and 80mm.
Materials: The cannulated screws are manufactured from medical grade BIODUR stainless steel which meet ASTM 2229-07 standard.
Function: The system, which includes the cortical screws, functions to provide immediate stability and temporary fixation during the natural healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone, femoral neck
Indicated Patient Age Range
pediatric and small stature adults
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)
Non-Clinical Tests: Engineering analysis was performed to show substantial equivalence between the subject device and predicate device.
Clinical Tests: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2016
OrthoPediatrics, Corp. Mr. Adam Cargill Regulatory Affairs Associate Manager 2850 Frontier Drive Warsaw, Indiana 46582
Re: K162307
Trade/Device Name: OrthoPediatrics Locking Proximal Femur System Cortical Screws 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: September 1, 2016 Received: September 2, 2016
Dear Mr. Cargill:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
OrthoPediatrics Locking Proximal Femur System Cortical Screws
Indications for Use (Describe)
The OrthoPediatrics Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.
| 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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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Locking Proximal Femur System Screws Special 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | OrthoPediatrics, Corp.
2850 Frontier Drive
Warsaw, IN 46582
Establishment Registration Number: 9102640
Phone: (574) 267-6379
Fax: (574) 269-3692 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Adam Cargill
Regulatory Affairs Associate Manager |
| Date: | September 26, 2016 |
| Subject Device: | Trade Name: OrthoPediatrics Locking Proximal Femur System Cortical Screws |
| | Regulation Number: 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliance
and accessories
Product Code: HRS |
| | Regulation Number: 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener
Product Code: HWC |
| | Common Name(s): Plate, Fixation, Bone
Screw, Fixation, Bone |
Legally marketed devices to which substantial equivalence is claimed:
- K111086 – OrthoPediatrics Locking Proximal Femur System
Device Description
The OrthoPediatrics Locking Proximal Femur System Cortical Screws are a line extension to expand the current offering to allow for longer cortical screws. The screws are part of one system that combines implants (plates and screws) and instruments. The additional cortical screw sizes include the following: 55mm, 60mm, 65mm, 70mm, 75mm, and 80mm.
- Materials: The cannulated screws are manufactured from medical grade BIODUR stainless steel ● which meet ASTM 2229-07 standard.
- . Function: The system, which includes the cortical screws, functions to provide immediate stability and temporary fixation during the natural healing process.
4
Intended Use and Indications for Use
The OrthoPediatrics Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.
Summary of Technological Characteristics
The technological characteristics (materials, design, sizing, and indications) of the Locking Proximal Femur System Cortical Screws are similar to the predicate system's screws.
The rationale for substantial equivalence is based on consideration of the following characteristics:
Intended Use: The proposed Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, malunions, and non-unions, in pediatric and small stature adults which is the same as the predicate device.
Indications for Use: The proposed Locking Proximal Femur System Cortical Screws Indications for Use are identical to the predicate devices.
Materials: The proposed Locking Proximal Femur System Cortical Screws use the identical implant material as the predicate system's screws.
Design Features: The proposed Locking Proximal Femur System Cortical Screws incorporate similar design features as the predicate system's screws with the difference being the length of the screw and the change from cannulated to solid.
Sterilization: The proposed Locking Proximal Femur System Cortical Screws are provided nonsterile, which is identical to the predicate device.
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
- Engineering analysis was performed to show substantial equivalence between the o subject device and predicate device.
- . Clinical Tests - None provided as a basis for substantial equivalence.
Substantial Equivalence Conclusion
OrthoPediatrics believes that the Locking Proximal Femur System Cortical Screws are substantially equivalent to the legally marketed predical screws (K111086) based on the similarities of design, intended use, materials, and the results of verification activities conducted. No new risks have been identified and it is expected that the Locking Proximal Femur System Cortical Screws will perform substantially equivalent to the legally marketed predicate device.