(134 days)
No
The device description focuses on the mechanical properties and materials of the nails and screws used for fracture fixation. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as an intramedullary nail system used to stabilize fractures of the femoral shaft and other long bones, which is a therapeutic intervention.
No
The device is a Pediatric Nailing Platform designed to stabilize fractures of the femur by aligning and fixing bone fragments with intramedullary nails and screws, indicating a therapeutic or treatment-oriented function rather than a diagnostic one.
No
The device description explicitly states that the device includes 316L stainless steel nails and screws, which are physical hardware components intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Pediatric Nailing Platform | Femur is a system of implants (nails, screws, end caps) made of stainless steel intended to be inserted into the medullary canal of the femur to stabilize bone fractures. This is an invasive surgical procedure performed directly on the patient's body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
The device is a surgical implant used for orthopedic fixation, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Pediatic Nailing Platform | Femur is used for pediatric and small stature as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The OrthoPediatrics Pediatric Nailing Platform | Femur is for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
Pediatric Nailing Platform | Femur includes 316L stainless steel nails which are intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments in small statue adults and pediatric populations. The nails are provided as child nails and adolescent nails. The child nails are available in diameters of 7, 8 and 9 mm with a length of 200 to 420 mm depending on the diameter. The adolescent nails are available in diameters of 9, 10, 11, 12 mm with a length of 280 to 500 mm depending on the diameter. The nails have holes at each end which allow 316L stainless steel transverse screws to be installed to achieve greater stabilization. The screws are available in 3.8, 4.0, 4.5 and 5.0 mm in diameter and 15-120 mm in length depending on the diameter. The end caps are used to cap the head of the nail to prevent bony ingrowth and ease removal of the nail. The Pediatric Nailing Platform | Femur was evaluated for use in an MR Environment and were determined to be MR Conditional. The Pediatric Nailing Platform | Femur system is implanted using class I exempt instruments.
The subject implants under this submission in the Pediatric Nailing Platform | Femur are for single use only and will be provided non-sterile. The class II and class I exempt instruments can be single use or reusable and they are also provided non-sterile. All class II instruments have been cleared under K172583. The devices must be sterilized by the end user before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral shaft, subtrochanteric, ipsilateral neck/shaft, long bones being treated
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)
Verification testing (Torsional Performance & Driving Torque, Axial Pullout, Bending Strength and Full Construct) was conducted to demonstrate that the new nails and screws added to the Pediatric Nailing Platform | Femur (K172583) meet the design input requirements identified based on the intended use of the device, including the needs of the user and patient, and where appropriate, applicable standards.
The subject devices to be added to the Pediatric Nailing Platform | Femur system (K172583) were evaluated for use in an MR Environment for the below requirements and were determined to be MR Conditional.
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.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
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July 20, 2022
OrthoPediatrics Corp. Yan Li Regulatory Affairs Manager 2850 Frontier Drive Warsaw, Indiana 46582
Re: K220679
Trade/Device Name: Pediatric Nailing Platform | Femur Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 14, 2022 Received: June 17, 2022
Dear Yan Li:
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.
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
1
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 mediation-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,
Jiping Chen, MD, PhD, MPH Acting Director DHT6A:Division of Joint Arthroplasty 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) K220679
Device Name Pediatric Nailing Platform | Femur
Indications for Use (Describe)
Pediatic Nailing Platform | Femur is used for pediatric and small stature as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The OrthoPediatrics Pediatric Nailing Platform | Femur is for single use only.
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/16 description: The image shows the OrthoPediatrics logo, which includes a smiling face with the word "Ortho" in blue and green, followed by the word "Pediatrics" in red. The logo also includes the text "K220679" and "Page 1 of 3" in the upper right corner. The logo is colorful and playful, suggesting a focus on children's health.
510(k) Summary
I. Submitter
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | OrthoPediatrics Corp. |
| Applicant Address: | 2850 Frontier Drive, Warsaw, IN 46582 |
| Establishment Registration Number: | 3006460162 |
| Contact: | Yan Li |
| Contact Phone: | (574) 267-0864 |
| Date Prepared: | March 4, 2022 |
II. Device
| Device Trade Name: | Pediatric Nailing Platform Femur |
|---|---|
| Regulation Number: | 21 CFR 888.3020 |
| Product Code: | HSB |
| Device Classification: | II |
| Common Name: | Rod, Fixation, Intramedullary and Accessories |
| Classification Panel: | Orthopedic |
III. Predicate Device
Substantial equivalence is claimed to the following predicate devices:
Predicate Device:
- PediNail Intramedullary Platform, K172583, OrthoPediatrics Corp. .
Note: PediNail Intramedullary Platform (K172583) has been marketed as Pediatric Nailing Platform | Femur System since the clearance of the sterile packed implants under K 190321.
Reference Device:
- PediNail Intramedullary Nailing System, K083726, OrthoPediatrics Corp. ●
IV. Device Description
Pediatric Nailing Platform | Femur includes 316L stainless steel nails which are intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments in small statue adults and pediatric populations. The nails are provided as child
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Image /page/4/Picture/1 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a child with a large head and a smiling face. The child is holding the word "OrthoPediatrics" in their hands, with the "Ortho" part of the word in blue and the "Pediatrics" part in red.
nails and adolescent nails. The child nails are available in diameters of 7, 8 and 9 mm with a length of 200 to 420 mm depending on the diameter. The adolescent nails are available in diameters of 9, 10, 11, 12 mm with a length of 280 to 500 mm depending on the diameter. The nails have holes at each end which allow 316L stainless steel transverse screws to be installed to achieve greater stabilization. The screws are available in 3.8, 4.0, 4.5 and 5.0 mm in diameter and 15-120 mm in length depending on the diameter. The end caps are used to cap the head of the nail to prevent bony ingrowth and ease removal of the nail. The Pediatric Nailing Platform | Femur was evaluated for use in an MR Environment and were determined to be MR Conditional. The Pediatric Nailing Platform | Femur system is implanted using class I exempt instruments.
The subject implants under this submission in the Pediatric Nailing Platform | Femur are for single use only and will be provided non-sterile. The class II and class I exempt instruments can be single use or reusable and they are also provided non-sterile. All class II instruments have been cleared under K172583. The devices must be sterilized by the end user before use.
V. Indications for Use
Pediatric Nailing Platform | Femur is used for pediatric and small patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures: severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The OrthoPediatrics Pediatric Nailing Platform | Femur is for single use only.
VI. Comparison of Technological Characteristics
The OrthoPediatrics Pediatric Nailing Platform | Femur and predicate devices share identical indications for use. The Pediatric Nailing Platform | Femur and the predicate devices also share the same principles of operation in the same anatomical sites, materials of construction, body contact and duration of contact, sterilization, packaging, design and fundamental technological characteristics.
The purpose of this submission is to obtain clearance of longer adolescent nails, longer fully threaded and partially threaded screws, and new 4.0 mm fully threaded screws to be added to the existing nails and screws cleared under Pediatric Nailing Platform | Femur (K172583). This submission is also to obtain clearance of new end caps which have a retaining function comparing with the end caps cleared under K172583. The longer adolescent nails do not impact the intended use or disease state. Rather, the longer adolescent nail options ensure the scope of Pediatric Nailing Platform | Femur adolescent nails covers a wider range of patient anatomy and matches competitor's offerings. Similarly, the addition of longer length options for 4.5 mm and 5.0 mm
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Image /page/5/Picture/1 description: The image shows a logo for OrthoPediatric. The logo features a cartoon drawing of a child with a smiling face and a green body. The text "OrthoPediatric" is written in a playful, handwritten font, with "Ortho" in blue and "Pediatric" in red. The overall design is colorful and whimsical, suggesting a child-friendly medical practice.
fully threaded screws and partially threaded screws and a dedicated 4.0 mm fully threaded screw will ensure that a wider range of patient anatomy is addressable within the system. The subject and predicate end caps share the exact same dimensions and intended use which is to cap the head of the nail to prevent bony ingrowth and ease removal of the nail. Performance testing has been conducted to support the differences between the subject and predicate device and to establish the substantial equivalence.
VII. Performance Data
Verification testing (Torsional Performance & Driving Torque, Axial Pullout, Bending Strength and Full Construct) was conducted to demonstrate that the new nails and screws added to the Pediatric Nailing Platform | Femur (K172583) meet the design input requirements identified based on the intended use of the device, including the needs of the user and patient, and where appropriate, applicable standards.
The subject devices to be added to the Pediatric Nailing Platform | Femur system (K172583) were evaluated for use in an MR Environment for the below requirements and were determined to be MR Conditional.
The Pediatric Nailing Platform | Femur System in its final finished form is identical to Pediatric Nailing Platform | Femur System (previously marketed device, cleared under K172583) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
VIII. Conclusion
The information provided above supports that the Pediatric Nailing Platform | Femur is as safe and effective as the predicate devices. Information and data provided within the submission support the differences between the subject and predicate devices. Therefore, it is concluded that the Pediatric Nailing Platform | Femur is substantially equivalent to the predicate devices.
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