(111 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a rigid intramedullary nail, with no mention of AI or ML technologies.
No.
The device is a temporary implant for mechanical support and stabilization of bones, not for therapeutic treatment of a disease or condition itself.
No
This device is an implantable intramedullary nail used for the stabilization and alignment of tibias after surgery or trauma. It provides structural support rather than diagnosing a condition.
No
The device description clearly states it is a system of rigid intramedullary nails and associated instruments, which are physical hardware components made of Ti-6A1-4V ELI.
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 taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Pediatric Nailing Platform | Tibia is an implantable medical device designed to be surgically inserted into the tibia bone for stabilization and alignment. It is a physical device that interacts directly with the patient's body.
- Intended Use: The intended use clearly describes a surgical procedure involving the bone itself, not the analysis of bodily specimens.
The description focuses on the mechanical properties and surgical application of the device within the patient's body, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Pediatric Nalling Platform | Tibia is intended as a temporary implant for alignment, stabilization of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained frauma or disease. The patient population is pediatric, including child and adolescent subgroups, and small-stature adults - such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Nail lengths greater than 400mm are for skeletally mature patients.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Pediatric Nailing Platform | Tibia offers a selection of rigid intramedullary nails for internal stabilization of the tibia. When a tibia is broken into multiple pieces, via a traumatic fracture(s), disease, or planned osteotomy(ies), alignment and stabilization of the bone fragments is critical to ensuring successful healing. When inserted down the intramedullary canal and locked with screws both proximally and distally, a rigid metallic nail provides resistance to bending and axial loading of the bone. In cases where compression is desired to stimulate bone regeneration, a dynamization slot can be utilized. End caps may be implanted with the nail, to ease removal by protecting the proximal threads of the nail and prevent bony ingrowth, as well preventing incarceration of the nail. All implants are single use and are made of Ti-6A1-4V ELI. The system is implanted using Class II and Class I exempt instruments. All implants and instruments in the system are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibias
Indicated Patient Age Range
pediatric, including child and adolescent subgroups, and small-stature adults - such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Nail lengths greater than 400mm are for skeletally mature 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 Biocompatibility assessment and testing for the Pediatric Nailing Platform | Tibia were performed in conformance with ISO 10993-1. The implants of Pediatric Nailing Platform | Tibia were evaluated for use in an MR Environment and were determined to be MR Conditional. Performance testing according to ASTM F1264 and ASTM F543 was conducted to demonstrate that the Pediatric Nailing Platform | Tibia meets 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.
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
§ 888.3020 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
August 21, 2023
OrthoPediatrics Corp. Yan Li Regulatory Affairs Manager 2850 Frontier Drive Warsaw, Indiana 46582
Re: K231266
Trade/Device Name: Pediatric Nailing Platform | Tibia Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 21, 2023 Received: July 21, 2023
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
1
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,
Farzana
Sharmin -S
Digitally signed by
Farzana Sharmin -S
Date: 2023.08.21 16:57:46
-04'00'
Farzana Sharmin, Ph.D. Assistant 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) K231266
Device Name Pediatric Nailing Platform | Tibia
Indications for Use (Describe)
The Pediatric Nalling Platform | Tibia is intended as a temporary implant for alignment, stabilization of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained frauma or disease. The patient population is pediatric, including child and adolescent subgroups, and small-stature adults - such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Nail lengths greater than 400mm are for skeletally mature 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 text "K231266-Page 1 of 3" at the top. Below that is a logo for "OrthoPediatrics". The logo includes a cartoon drawing of a person with a smiley face. The text "Ortho" is in blue, and the text "Pediatrics" is in red.
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: | August 18, 2023 |
II. Device
| Device Trade Name: | Pediatric Nailing Platform Tibia |
|---|---|
| Regulation Number: | 21 CFR 888.3020 |
| Regulation Name: | Intramedullary Fixation Rod |
| Device Classification: | II |
| Classification Panel: | Orthopedic |
| Classification Product Code: | HSB |
| Device Classification Name | Rod, Fixation, Intramedullary and Accessories |
III. Predicate Device and Reference Device
Substantial equivalence is claimed to the following predicate device:
Predicate Device:
- Primary predicate: Simple Locking Intramedullary (SLIM) System ● (K192710, Pega Medical Inc., now owned by OrthoPediatrics Corp.)
- Secondary predicate: GAP Endo-Exo Medullary System .
(K160545, Pega Medical Inc. now owned by OrthoPediatrics Corp.)
- Secondary predicate: Affixus Tibial Nailing System (K150867, Biomet Incorporated, now owned by Zimmer Biomet)
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Image /page/4/Picture/1 description: The image shows the text 'K231266-Page 2 of 3'. The text appears to be a document identifier and page number. The document identifier is K231266, and the page number is 2 of 3, indicating that this is the second page of a three-page document.
Image /page/4/Picture/2 description: The image is a logo for OrthoPediatrics. The logo features a cartoon drawing of a smiling face with a body made of a green banana. The text "OrthoPediatrics" is written in a playful, handwritten font, with "Ortho" in blue and "Pediatrics" in red.
IV. Device Description
The Pediatric Nailing Platform | Tibia offers a selection of rigid intramedullary nails for internal stabilization of the tibia. When a tibia is broken into multiple pieces, via a traumatic fracture(s), disease, or planned osteotomy(ies), alignment and stabilization of the bone fragments is critical to ensuring successful healing. When inserted down the intramedullary canal and locked with screws both proximally and distally, a rigid metallic nail provides resistance to bending and axial loading of the bone. In cases where compression is desired to stimulate bone regeneration, a dynamization slot can be utilized. End caps may be implanted with the nail, to ease removal by protecting the proximal threads of the nail and prevent bony ingrowth, as well preventing incarceration of the nail. All implants are single use and are made of Ti-6A1-4V ELI. The system is implanted using Class II and Class I exempt instruments. All implants and instruments in the system are provided non-sterile.
V. Indications for Use
Pediatric Nailing Platform | Tibia is intended as a temporary implant for alignment, stabilization and fixation of tibias that have been surgically prepared (osteotomy) for correction of deformities or have sustained fracture due to trauma or disease. The patient population is pediatric, including child and adolescent subgroups, and small-stature adults - such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases. Nail lengths greater than 400mm are for skeletally mature patients.
VI. Comparison of Technological Characteristics
The subject device Pediatric Nailing Platform | Tibia and the previously cleared predicate device Simple Locking Intramedullary (SLIM) System (K192710) are substantially equivalent in that these devices share the same intended use, principles of operation, same patient population when used in deformity correction and fracture fixation of the tibia, and many fundamental technological characteristics. There are some differences between the predicate and subject devices in terms of system components, dimensions, materials, and MR safety labeling. The performance data provided in this submission supported that the differences between the subject and predicate devices do not raise different questions for safety and effectiveness.
VII. Performance Data
The Biocompatibility assessment and testing for the Pediatric Nailing Platform | Tibia were performed in conformance with ISO 10993-1. The implants of Pediatric Nailing Platform | Tibia were evaluated for use in an MR Environment and were determined to be MR Conditional. Performance testing according to ASTM F1264 and ASTM F543 was conducted to demonstrate that the Pediatric Nailing Platform | Tibia meets the design input requirements identified based
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Image /page/5/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a child's face with a smiling expression. The word "OrthoPediatrics" is written in a playful, handwritten font, with the "Ortho" part in blue and the "Pediatrics" part in red. The logo is designed to be friendly and approachable, reflecting the company's focus on pediatric orthopedics.
on the intended use of the device, including the needs of the user and patient, and where appropriate, applicable standards.
VIII. Conclusion
The information provided above supports that the Pediatric Nailing Platform | Tibia 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 do not raise different questions for safety and effectiveness. Therefore, it is concluded that the Pediatric Nailing Platform | Tibia is substantially equivalent to the predicate devices.
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