(60 days)
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.
Line extension includes 1.5 and 4.5 mm diameters in 300mm and 450 mm lengths, respectively, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed. Note: the two diameters shown in bold are line extensions to our (Titanium) PediFlex system cleared though K081097, which is currently available in 2.0, 2.5, 3.0, 3.5, and 4.0mm diameters. The device is the same as flexible pins and ender nails that have been used to fix fractures in long bones for years in an intramedullary fashion. When these types of nails are used, they will be used in opposing pairs. The nail will be bent to provide three-point fixation. The ideal fixation points will be at the insertion site, the fracture site, and some point beyond the fracture site. Materials: The devices are manufactured from Ti-6Al-4V which meets the ASTM-F136 standard, and 316L stainless steel which meets the ASTM-F138 standard. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
The provided text describes a medical device, the OrthoPediatrics PediFlex™ Flexible Nail System, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a 510(k) premarket notification approval letter from the FDA. In 510(k) submissions, manufacturers demonstrate that their new device is "substantially equivalent" to a legally marketed predicate device. This often involves showing similar design, materials, and intended use, and may include performance testing to ensure the new device performs as safely and effectively as the predicate. However, detailed acceptance criteria and a specific study report proving the device meets those criteria are not present in the provided text.
Based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. The document focuses on substantial equivalence to predicate devices (K081097, K971783, K042135, K053105, K032687, K000764, K081452, K063225) based on similarities in design, materials, and indications for use. | Not explicitly stated as performance data from a specific study within the provided text. The document implies performance is considered equivalent to predicate devices, which are already marketed and assumed to perform acceptably. The device is made of Ti-6Al-4V (ASTM-F136) and 316L stainless steel (ASTM-F138) and functions to provide immediate stability and temporary fixation during healing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not mentioned.
- Data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not mentioned. This type of information is typically associated with studies involving expert review of data, which is not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study is mentioned. This device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device (intramedullary nail), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of this document. For physical devices demonstrating substantial equivalence, "ground truth" often relates to adherence to material standards, functional testing, and clinical outcomes of predicate devices, which are not detailed here. The submission relies on established safety and effectiveness of similar devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm.
Summary of what the document does provide:
- Device Name: OrthoPediatrics PediFlex™ Flexible Nail System
- Manufacturer: OrthoPediatrics, Corp.
- Device Type: Intramedullary Elastic Nail (line extension including 1.5mm and 4.5mm diameters in 300mm and 450mm lengths).
- Materials: Ti-6Al-4V (ASTM-F136) and 316L stainless steel (ASTM-F138).
- Function: Provides immediate stability and temporary fixation for long bone fractures.
- Indications for Use: Fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility is required, including upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients (designed not to disturb growth plates in pediatric patients).
- Basis for Substantial Equivalence: Similarities in design, materials, and indications to several predicate devices (listed in the text).
- FDA Approval: Cleared with 510(k) Number K082375 on October 17, 2008.
The document essentially states that the new PediFlex line extension is substantially equivalent to existing, legally marketed devices, implying that its performance is acceptable based on the history and regulatory clearance of those predicates. It does not elaborate on new performance studies with specific acceptance criteria beyond material and general functional descriptions.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | OrthoPediatrics, Corp.210 N. Buffalo StreetWarsaw, Indiana 46580Establishment Registration No.: 9102640 |
|---|---|
| 510(K) CONTACT: | Gary BarnettVP-Regulatory, Engineering & OperationsTel: (574) 268-6379Fax: (574) 269-3692 |
| TRADE NAME: | OrthoPediatrics PediFlexTM Flexible Nail System |
| COMMON NAME: | Intramedullary Elastic Nail |
| CLASSIFICATION: | 21 CFR 888.3040 Smooth or threaded metallicbone fastener: Class II per 21 CFR §888.3040 |
DEVICE PRODUCT CODE(S):
SUBSTANTIALLY EQUIVALENT DEVICES:
Pedi-Flex Nail (K081097), OrthoPediatrics, Corp. Synthes EIN (K971783, K042135, K053105), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc. Pediatric Fixation Rods (K000764), Biomet, Inc. Synthes EIN (K081452), Synthes (USA) Metaizeau Nailing System (K063225), Howmedica
DEVICE DESCRIPTION:
Line extension includes 1.5 and 4.5 mm diameters in 300mm and 450 mm lengths, respectively, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed. Note: the two diameters shown in bold are line extensions to our (Titanium) PediFlex system cleared though K081097, which is currently available in 2.0, 2.5, 3.0, 3.5, and 4.0mm diameters.
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The device is the same as flexible pins and ender nails that have been used to fix fractures in long bones for years in an intramedullary fashion. When these types of nails are used, they will be used in opposing pairs. The nail will be bent to provide three-point fixation. The ideal fixation points will be at the insertion site, the fracture site, and some point beyond the fracture site.
- . Materials: The devices are manufactured from Ti-6Al-4V which meets the ASTM-F136 standard, and 316L stainless steel which meets the ASTM-F138 standard.
- . Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
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.
BASIS FOR SUBSTANTIAL EQUIVALENCE:
OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials, and indications.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three thick, curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2008
OrthoPediatrics Corporation % Mr. Gary D. Barnett VP, Regulatory, Engineering & Operations 210 N. Buffalo Street Warsaw. Indiana 46580
Re: K082375
Trade/Device Name: OrthoPediatrics PediFlex™ Flexible Nail System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: August 13, 2008 Received: August 18, 2008
Dear Mr. Barnett:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); good manufacturing practice requirements as set 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.
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Page 2 - Mr. Gary D. Barnett
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark N. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K082375
Device Name: OrthoPediatrics PediFlex ™ Flexible Nail System
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nielke Onderdonk
(Division Sign-Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K082375
§ 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.