(147 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and intended use of a traditional intramedullary nail system. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is described as an intramedullary nail and screws intended to provide temporary stabilization and fixation for various types of fractures, nonunions, and malunions in the femur, tibia, and humerus, which are all conditions that require therapeutic intervention to promote healing and restore function.
No.
The device is described as an intramedullary nail and screws intended for femoral, tibial, and humeral fracture fixation, providing temporary stabilization. Its purpose is to treat fractures, not to diagnose them.
No
The device description explicitly states it consists of "metal rods, bone screws, and end caps," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the fixation and stabilization of bone fractures and related conditions (pseudoarthrosis, osteotomy, etc.). This is a therapeutic and structural function within the body.
- Device Description: The device is described as a metal rod, screws, and end caps implanted into the medullary cavity of a bone. This is an implantable medical device used for mechanical support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. There is no mention of analyzing biological samples like blood, urine, or tissue.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to treat a physical condition (fractures).
N/A
Intended Use / Indications for Use
Intramedullary Nail and Screws for Femur - NEONAIL is indicated for femoral fracture fixation including:
- Open and closed femoral fractures;
- Pseudoarthrosis and correction osteotomy;
- Pathologic fractures, impending pathologic fractures, and tumor resections;
- Ipsilateral femur fractures;
- Fractures distal to the hip joint; and
- Nonunions and malunions.
Intramedullary Nail and Screws for Tibia - NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions or nonunions of the tibia. Intramedullary Nail and Screws for Tibia - NEONAIL is indicated for tibial fracture fixation, which may include:
- . Open and closed tibial fractures:
- . Pseudoarthodlosis and correction osteotomy;
- Pathologic fractures, impending pathological fractures and tumor resections; and
- Nonunions and malunions.
The Intramedullary Nail and Screws for Humerus - NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Intramedullary Nail and Screws – NEONAIL consists of metal rods, bone screws, and end caps. All components are made from Ti-6AI-4V alloy. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Tibia, Humerus
Indicated Patient Age Range
Not Found
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 data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and mechanical testing. The worst case nail for each indication in the Intramedullary Nail and Screws - NEONAIL product list was subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending, static torsion, and bending fatigue).
The worst case screws available in the Intramedullary Nail and Screws – NEONAIL product list were subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending and bending fatigue) and ASTM F543 Standard Specification and Test Method for Metallic Bone Screws (torsional properties, driving torque, axial pullout strength, and self-tapping performance).
Clinical data were not submitted in this premarket notification.
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.
K010801, K112059, K131365, K042396, K032523
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.
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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 a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the figure in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2014
NEOORTHO Produtos Ortopédicos S/A % Mr. Kevin A. Thomas, PhD PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130
Re: K141103
Trade/Device Name: Intramedullary Nail and Screws - NEONAIL Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 28, 2014 Received: August 28, 2014
Dear Dr. Thomas:
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 Part 801); medical device 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page
1
510(k) Number (if known) K141103
Device Name
Intramedullary Nail and Screws - NEONAIL
Indications for Use (Describe)
Intramedullary Nail and Screws for Femur - NEONAIL is indicated for femoral fracture fixation including:
- · Open and closed femoral fractures;
- · Pseudoarthrosis and correction osteotomy;
- · Pathologic fractures, impending pathologic fractures, and tumor resections;
- · Ipsilateral femur fractures;
- · Fractures distal to the hip joint; and
- Nonunions and malunions.
Intramedullary Nail and Screws for Tibia - NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions or nonunions of the tibia. Intramedullary Nail and Screws for Tibia - NEONAIL is indicated for tibial fracture fixation, which may include:
- · Open and closed tibial fractures;
- · Pseudoarthodlosis and correction osteotomy;
- · Pathologic fractures, impending pathologic fractures and tumor resections; and
- · Nonunions and malunions.
The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary NEOORTHO Produtos Ortopédicos S/A Intramedullary Nail and Screws – NEONAIL K141103
September 18, 2014
ADMINISTRATIVE INFORMATION
| Manufacturer Name | NEOORTHO Produtos Ortopédicos S/A
Rua Ângelo Domingos Durigan, 607, Cascatinha
Curitiba, Paraná 82025-100, Brazil | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------|
| | Telephone: | +55 41 3535-1000 |
| | Fax: | +55 41 3535-1018 |
| Official Contact | Mariana de Oliveira Quinzani | |
| | Regulatory Affairs | |
| Representative/Consultant | Kevin A. Thomas, PhD | |
| | Floyd G. Larson | |
| | PaxMed International, LLC | |
| | 12264 El Camino Real, Suite 400 | |
| | San Diego, CA 92130 | |
| | Telephone: | +1 (858) 792-1235 |
| | Fax: | +1 (858) 792-1236 |
| | Email: | kthomas@paxmed.com |
| | | flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Intramedullary Nail and Screws - NEONAIL |
|---|---|
| Common Name | Rod, fixation, intramedullary and accessories |
| Classification Name | Intramedullary fixation rod |
| Classification Regulations | 21 CFR 888.3020, Class II |
| Product Code | HSB |
| Classification Panel | Orthopedic Products Panel |
| Reviewing Branch | Joint Fixation Branch One |
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INTENDED USE
Device Name: Intramedullary Nail and Screws - NEONAIL Femur
Intramedullary Nail and Screws for Femur – NEONAIL is indicated for femoral fracture fixation including:
- Open and closed femoral fractures;
- Pseudoarthrosis and correction osteotomy;
- Pathologic fractures, impending pathologic fractures, and tumor resections;
- Ipsilateral femur fractures;
- Fractures distal to the hip joint; and ●
- Nonunions and malunions. ●
Device Name: Intramedullary Nail and Screws - NEONAIL Tibia
Intramedullary Nail and Screws for Tibia – NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions of the tibia. Intramedullary Nail and Screws for Tibia – NEONAIL is indicated for tibial fracture fixation, which may include:
- . Open and closed tibial fractures:
- . Pseudoarthodlosis and correction osteotomy;
- Pathologic fractures, impending pathologic fractures and tumor resections; and ●
- Nonunions and malunions. ●
Intramedullary Nail and Screws - NEONAIL Device Name: Humerus
The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.
DEVICE DESCRIPTION
An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Intramedullary Nail and Screws – NEONAIL consists of metal rods, bone screws, and end caps. All components are made from Ti-6AI-4V alloy. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.
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EQUIVALENCE TO MARKETED DEVICE
Intramedullary Nail and Screws - NEONAIL is substantially equivalent in indications and design principles to the following predicate devices:
- Howmedica Osteonics Corp., T2 Femoral Nail, K010801
- Stryker, T2 Femoral Nail Model 1825-XXXXCP, 1828-XXXXCP, K112059 ●
- Stryker Trauma AG, T2 Tibial Nailing System, K131365 ●
- Howmedica Osteonics Corp., T2 Proximal Humeral Nail, K042396 ●
- Howmedica Osteonics Corp., T2 Nailing System, K032523 ●
Intramedullary Nail and Screws – NEONAIL components have similar designs and identical materials as those cleared under K010801, K112059, K131365, K042396, and K032523. Intramedullary Nail and Screws for Femur – NEONAIL is similar in indications, design, and dimensions to those cleared in K010801 and K112059. Intramedullary Nail and Screws for Tibia - NEONAIL is similar in indications, design, and dimensions to those cleared in K131365. Intramedullary Nail and Screws for Humerus – NEONAIL is similar in indications, design, and dimensions to those cleared in K042396 and K032523.
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and mechanical testing. The worst case nail for each indication in the Intramedullary Nail and Screws - NEONAIL product list was subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending, static torsion, and bending fatigue).
The worst case screws available in the Intramedullary Nail and Screws – NEONAIL product list were subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending and bending fatigue) and ASTM F543 Standard Specification and Test Method for Metallic Bone Screws (torsional properties, driving torque, axial pullout strength, and self-tapping performance).
Clinical data were not submitted in this premarket notification.
Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
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510(k) Summary K141103
Overall, Intramedullary Nail and Screws – NEONAIL has the following similarities to the predicate devices:
- has the same intended use, ●
- uses the same operating principle,
- incorporates the same basic design,
- incorporates the same materials, and .
- has similar packaging. ●