(211 days)
Not Found
No
The device description and performance studies focus on the mechanical properties, materials, and MR compatibility of a physical implant system for bone fracture repair. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as "aiding bone fracture repair and healing," which directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The PediFlex™ Flexible Nail System is intended for fixing diaphyseal fractures of long bones (treatment), not for diagnosing medical conditions.
No
The device description explicitly details physical components made of stainless steel and titanium, including flexible nails, interlocking clamps, and screws, which are implanted into the body. This is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of diaphyseal fractures of long bones." This is a surgical procedure performed on the body.
- Device Description: The description details implants (flexible nails, interlocking clamps, screws) and instruments used for bone fracture repair. These are physical devices used within the body or to manipulate devices within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures and lower extremity fractures in pediatric or small stature patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The PediFlex™Flexible Nail System includes stainless steel and titanium flexible nails, interlocking clamps, and clamp screws for the application of aiding bone fracture repair and healing. The PediFlex™Flex™Flexible Nail System was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class I exempt instruments.
The PediFlex™ flexible nails are provided in 316L stainless steel and titanium alloy (Ti-6A1-4V). The 316L stainless steel flexible nails are available in diameters ranging from 1.5 mm to 4.0 mm in increments of 0.5 mm. The titanium allov (Ti-6Al-4V) flexible nails are available in diameters ranging from 1.5 mm to 4.5 mm in increments of 0.5 mm. The tip of the flexible nails is available in two designs, the round tip and the advanced round tip. Both tip designs are provided in 316L stainless steel and titanium alloy (Ti-6Al-4V) in various diameters and lengths. The PediFlex™ interlocking clamps are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. Using the interlocking Clamps is optional in the surgery. The interlocking clamps are manufactured from both 316L stainless steel and titanium allov (Ti-6Al-4V) materials. The 316L stainless steel interlocking Clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm and 4.0 mm which are to be used with 316L stainless steel flexible nails in diameters of 3.0 mm. 3.5 mm and 4.0 mm. The 316L stainless steel clamp screws are available in 15 mm, and 35 mm in length. The titanium alloy (Ti-6A1-4V) interlocking Clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm which are to be used with titanium alloy (Ti-6AI-4V) flexible nails in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm. The titanium alloy (Ti-6Al-4V) clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The material of the clamp must match the material of the nail and screw in the surgery.
The system is implanted using Class I exempt instruments. The Class II instruments in the system include hex drivers which are for installing the clamp screws and the hex easy out which is to remove the clamp screws if the hex strips. The instruments in the system are Class I exempt.
The implants in the PediFlex™ Flexible Nail System are for single use only and will be provided non-sterile. The instruments in the PediFlex™ Flexible Nail System are reusable, except for the Hex Easy Out instrument which is single use. Instruments are also provided non-sterile. 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
diaphyseal fractures of long bones, upper extremity fractures, lower extremity fractures
Indicated Patient Age Range
pediatric or small stature patients, all patients (for upper extremity fractures)
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)
Performance testing was conducted to demonstrate that the PediFlex™ Flexible Nail System 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.
Verification Testing:
- VerRep-1001-0003 PediFlex ILC Construct Test
- VerRep-1001-0009 ILC ASTM F543
Validation Testing:
- ValRep-1001-0001 PediFlex Advanced Validation
- ValRep-1001-0004 PediFlex ILC Validation
- ValRep-1001-0008 PediFlex ILC Usability
MR Compatibility Testing:
The PediFlex™ Flexible Nail System implants were evaluated for use in an MR Environment and were determined to be MR Conditional. The following testing data were provided in support of MR compatibility.
- . MRER-1001-001 PediFlex Advanced MRER
- VerRep-9999-0007 MR Compatibility Force and Torque
- VerRep-9999-0008 MR Compatibility Artifact Testing
- VerRep-9999-0014 MR Heating PediFlex .
Biocompatibility Testing:
Biocompatibility testing for the PediFlex™ Flexible Nail System was performed in conformance with ISO 10993-1.
- VerRep-0999-0006 Solid IM Nails Biocompatibility
- VerRep-0999-0009 Instrument Biocompatibility
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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29 January 2021
Image /page/0/Picture/1 description: The image contains 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.
OrthoPediatrics Corp. Yan Li Regulatory Affairs Associate Manager 2850 Frontier Drive Warsaw, Indiana 46582
Re: K201838
Trade/Device Name: PediFlex Flexible Nail System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: December 21, 2020 Received: December 23, 2020
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,
For Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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 PediFlex™ Flexible Nail System
Indications for Use (Describe)
The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures and lower extremity fractures in pediatric or small stature patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
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 is a logo for OrthoPediatrics. The logo features a cartoon drawing of a child with a big smile. The child is holding a banana in their left hand. The text "OrthoPediatrics" is written in a playful font to the right of the child.
510(k) Summary
Submitter I.
| 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: | January 28, 2021 |
II. Device
| Device Trade Name: | PediFlex™ Flexible Nail System |
|---|---|
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HTY |
| Device Classification: | II |
| Common Name: | Pin, Fixation, Smooth |
| Classification Panel: | Orthopedic |
III. Predicate Device
Substantial equivalence is claimed to the following predicate devices:
Primary predicate:
- Orthopediatrics PediFlex™ Flexible Nail System, K082375, OrthoPediatrics Corp. ●
Secondary predicate:
- Orthopediatrics PediFlex™ Flexible Nail System, K081097, OrthoPediatrics Corp. ●
IV. Device Description
The PediFlex™Flexible Nail System includes stainless steel and titanium flexible nails, interlocking clamps, and clamp screws for the application of aiding bone fracture repair and healing. The PediFlex™Flex™Flexible Nail System was evaluated for use in an MR Environment and were determined to be MR Conditional. The system is implanted using Class I exempt instruments.
The PediFlex™ flexible nails are provided in 316L stainless steel and titanium alloy (Ti-6A1-4V). The 316L stainless steel flexible nails are available in diameters ranging from 1.5 mm to 4.0 mm
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Image /page/4/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a smiling face with a banana-shaped body and a small hand. The text "OrthoPediatrics" is written in a playful, handwritten font, with the "Ortho" in blue and the "Pediatrics" in red.
in increments of 0.5 mm. The titanium allov (Ti-6Al-4V) flexible nails are available in diameters ranging from 1.5 mm to 4.5 mm in increments of 0.5 mm. The tip of the flexible nails is available in two designs, the round tip and the advanced round tip. Both tip designs are provided in 316L stainless steel and titanium alloy (Ti-6Al-4V) in various diameters and lengths. The PediFlex™ interlocking clamps are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. Using the interlocking Clamps is optional in the surgery. The interlocking clamps are manufactured from both 316L stainless steel and titanium allov (Ti-6Al-4V) materials. The 316L stainless steel interlocking Clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm and 4.0 mm which are to be used with 316L stainless steel flexible nails in diameters of 3.0 mm. 3.5 mm and 4.0 mm. The 316L stainless steel clamp screws are available in 15 mm, and 35 mm in length. The titanium alloy (Ti-6A1-4V) interlocking Clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm which are to be used with titanium alloy (Ti-6AI-4V) flexible nails in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm. The titanium alloy (Ti-6Al-4V) clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The material of the clamp must match the material of the nail and screw in the surgery.
The system is implanted using Class I exempt instruments. The Class II instruments in the system include hex drivers which are for installing the clamp screws and the hex easy out which is to remove the clamp screws if the hex strips. The instruments in the system are Class I exempt.
The implants in the PediFlex™ Flexible Nail System are for single use only and will be provided non-sterile. The instruments in the PediFlex™ Flexible Nail System are reusable, except for the Hex Easy Out instrument which is single use. Instruments are also provided non-sterile. The devices must be sterilized by the end user before use.
V. Indications for Use
The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
VI. Comparison of Technological Characteristics
The PediFlex™ Flexible Nail System and predicate devices share identical indications for use, which is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
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Image /page/5/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a smiling face with a blue outline and a green body. The text "OrthoPediatrics" is written in a playful, handwritten font, with "Ortho" in blue and "Pediatrics" in red.
The PediFlex™ Flexible Nail System 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, and fundamental technological characteristics; and they have similar dimensions and design features for implants and components types.
The modifications to the nail tip design for the stainless steel and titanium flexible nails in the PediFlex™ Flexible Nail System are line extensions of the flexible nails in the PediFlex™ Flexible Nail System cleared in K081097 and K082375. They have same materials of construct, dimensions, principal of operation and the only difference is the tip design. which does not create a new worst case or affect the strength of the implant. Therefore, these minor differences in tip design do not raise new questions of safety or effectiveness.
Components introduced in this submission include the interlocking clamps and clamp screws. The clamp and clamp screws are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. Using the interlocking clamps is optional in the surgery. Successful performance testing has been conducted on the clamps and clamp screws to demonstrate their substantial equivalence.
The predicate devices have not been evaluated in an MR environment. The subject device PediFlex™ Flexible Nail System was evaluated for use in an MR Environment and was determined to be MR Conditional.
VII. Performance Data
Performance testing was conducted to demonstrate that the PediFlex™ Flexible Nail System 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. The following performance data is provided in support of the substantial equivalence determination:
Verification Testing:
- VerRep-1001-0003 PediFlex ILC Construct Test ●
- VerRep-1001-0009 ILC ASTM F543
Validation Testing:
- ValRep-1001-0001 PediFlex Advanced Validation ●
- ValRep-1001-0004 PediFlex ILC Validation ●
- ValRep-1001-0008 PediFlex ILC Usability ●
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Image /page/6/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a smiling face with a banana body and a small hand. The text "OrthoPediatrics" is written in a playful, handwritten font, with "Ortho" in blue and "Pediatrics" in red.
The PediFlex™ Flexible Nail System implants were evaluated for use in an MR Environment and were determined to be MR Conditional. The following testing data were provided in support of MR compatibility.
- . MRER-1001-001 PediFlex Advanced MRER
- VerRep-9999-0007 MR Compatibility Force and Torque ●
- VerRep-9999-0008 MR Compatibility Artifact Testing ●
- VerRep-9999-0014 MR Heating PediFlex .
Biocompatibility testing for the PediFlex™ Flexible Nail System was performed in conformance with ISO 10993-1. The following test reports are provided to support the biocompatibility of the subject devices.
- VerRep-0999-0006 Solid IM Nails Biocompatibility .
- VerRep-0999-0009 Instrument Biocompatibility ●
| A list of FDA recognized standards used for the evaluation of the performance of the devices | |
|---|---|
| have been listed in the table. |
| FDA
Recognition
| Number | Standard Reference | Standard Title |
|---|---|---|
| 11-327 | ASTM F543-17 | Standard Specification and Test Methods for Metallic |
| Medical Bone Screws | ||
| 8-422 | ASTM F2052-15 | Standard Test Method for Measurement of Magnetically |
| Induced Displacement Force on Medical Devices in the | ||
| Magnetic Resonance Environment | ||
| 8-153 | ASTM F2119-07/(R)2013 | Standard Test Method for Evaluation of MR Image Artifacts |
| from Passive Implants | ||
| 8-227 | ASTM F2182-11a | Standard Test Method for Measurement of Radio Frequency |
| Induced Heating on or Near Passive Implants During | ||
| Magnetic Resonance Imaging | ||
| 8-466 | ASTM F2213-17 | Standard Test Method for Measurement of Magnetically |
| Induced Torque on Medical Devices in the Magnetic | ||
| Resonance Environment | ||
| 5-114 | ANSI AAMI IEC | |
| 62366-1:2015 | Medical Devices - Application of usability engineering to | |
| medical devices | ||
| 2-220 | ANSI AAMI ISO | |
| 10993-1:2018 | Biological evaluation of medical devices - Part 1: | |
| Evaluation and testing within a risk management process | ||
| (ISO 10993-1:2009) | ||
| 2-245 | ANSI AAMI ISO | |
| 10993-5:2009/(R)2014 | Biological evaluation of medical devices - Part 5: Tests for | |
| in vitro cytotoxicity |
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Image /page/7/Picture/2 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a child with a smiling face and a hand holding a banana. The text "OrthoPediatrics" is written in a playful, handwritten font, with the "Ortho" in blue and the "Pediatrics" in red.
| FDA
Recognition
| Number | Standard Reference | Standard Title |
|---|---|---|
| 2-174 | ANSI AAMI ISO | |
| 10993-10: 2010/(R)2014 | Biological evaluation of medical devices – Part 10: Tests for | |
| irritation and skin sensitization | ||
| 2-237 | ANSI AAMI ISO | |
| 10993-17: 2002/(R)2012 | Biological evaluation of medical devices. Establishment of | |
| allowable limits for leachable substances |
VIII. Conclusion
The information provided above supports that the PediFlex™Flexible Nail System is substantially equivalent to 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 PediFlex™ Flexible Nail System is substantially equivalent to the predicate devices.