(110 days)
Not Found
No
The device description details a system of plates and screws for bone fixation, with no mention of software, algorithms, or any technology that would incorporate AI or ML.
Yes
The device is intended for small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation, which are all therapeutic interventions designed to treat medical conditions.
No
This device is described as a "Mini and Micro Fragments Reconstruction System" intended for "small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation," and consists of "plates and screws." These functions are therapeutic or reconstructive, not diagnostic.
No
The device description explicitly details physical components (plates and screws made of titanium) and their dimensions and materials, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation." This describes a surgical implant used to physically stabilize bones.
- Device Description: The description details plates and screws made of titanium, which are physical components designed for surgical implantation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens for diagnostic purposes.
Therefore, the Mini and Micro Fragments Reconstruction System – NEOFIX is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mini and Micro Fragments Reconstruction System - NEOFIX is intended for small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation. Examples include small bones of the hand, wrist, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
Mini and Micro Fragments Reconstruction System – NEOFIX consists of plates and screws in a variety of designs and sizes. Straight plates are provided in various lengths and may be contoured to adapt to patient specific anatomy. Straight plates are available with screw holes to accommodate non-locking and locking screw designs. Plates also are provided in various geometric configurations that are commonly used in trauma and reconstructive surgery. The plates range in thickness from 0.7 mm to 2.7 mm, and are manufactured from commercially pure titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications or Ti-6Al-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Self-tapping cortical screws are provided in locking and non-locking designs. The locking screws are provided with a thread diameter of 2.4 mm with a hexalobular instrument interface (Star Head) and a tapered thread tip to facilitate insertion. Locking smooth pins also are provided with a diameter of 2.4 mm in various lengths. The smooth pins are used with the Distal Radius Volar Plates. Non-locking cortical self-tapping screws are provided with thread diameters of 1.5, 2.0, 2.3, 2.4 and 2.7 mm, and in various lengths from 5 mm to 32 mm. The non-locking screws with thread diameters of 1.5, 2.0 and 2.3 mm have a cruciform instrument interface; the nonlocking screws with diameters of 2.4 and 2.7 mm have a hexalobular instrument interface. All screws are manufactured from Ti-6AI-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand, wrist, foot and ankle
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)
Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject and predicate device designs, engineering analysis, and mechanical testing of the subject designs.
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.
K090047, K063049, K102694, K071184, K083694, K091644, K092556, K012114, K102641, K982732, K113733
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles within the eagle's body. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Neoortho Productos Orthopedicos S/A % Mr. Kevin Thomas Regulatory Affairs PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, California 92130
December 16, 2014
Re: K142419
Trade/Device Name: Mini and Micro Fragments Reconstruction System-Neofix Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 15, 2014 Received: October 16, 2014
Dear Mr. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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/ResourcesforYou/Industry/default.htm. 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
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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142419
Device Name
Mini and Micro Fragments Reconstruction System - NEOFIX
Indications for Use (Describe)
Mini and Micro Fragments Reconstruction System - NEOFIX is intended for small bone fracture fixation, arthrodess. reconstruction, and osteotomy fixation. Examples include small bones of the hand, wrist, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
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)
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3
510(k) Summary NEOORTHO Produtos Ortopédicos S/A Mini and Micro Fragments Reconstruction System – NEOFIX K142419
December 8, 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: | ||
Fax: | ||
Email: | ||
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name | Mini and Micro Fragments Reconstruction System – NEOFIX |
---|---|
Common Name | Plate, Fixation, Bone |
Screw, Fixation, Bone | |
Classification Name | Single/multiple component metallic bone fixation appliances and |
accessories | |
Smooth or threaded metallic bone fixation fastener | |
Classification Regulations | |
Product Code | 21 CFR 888.3030, 21 CFR 888.3040, Class II |
HRS, HWC | |
Classification Panel | |
Reviewing Branch | Orthopedic Products Panel |
Joint Fixation Devices Branch Two (JFDB2) |
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INTENDED USE
Mini and Micro Fragments Reconstruction System – NEOFIX is intended for small bone fracture fixation, arthrodesis, reconstruction, and osteotomy fixation. Examples include small bones of the hand, wrist, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
DEVICE DESCRIPTION
Mini and Micro Fragments Reconstruction System – NEOFIX consists of plates and screws in a variety of designs and sizes. Straight plates are provided in various lengths and may be contoured to adapt to patient specific anatomy. Straight plates are available with screw holes to accommodate non-locking and locking screw designs. Plates also are provided in various geometric configurations that are commonly used in trauma and reconstructive surgery. The plates range in thickness from 0.7 mm to 2.7 mm, and are manufactured from commercially pure titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications or Ti-6Al-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
Self-tapping cortical screws are provided in locking and non-locking designs. The locking screws are provided with a thread diameter of 2.4 mm with a hexalobular instrument interface (Star Head) and a tapered thread tip to facilitate insertion. Locking smooth pins also are provided with a diameter of 2.4 mm in various lengths. The smooth pins are used with the Distal Radius Volar Plates. Non-locking cortical self-tapping screws are provided with thread diameters of 1.5, 2.0, 2.3, 2.4 and 2.7 mm, and in various lengths from 5 mm to 32 mm. The non-locking screws with thread diameters of 1.5, 2.0 and 2.3 mm have a cruciform instrument interface; the nonlocking screws with diameters of 2.4 and 2.7 mm have a hexalobular instrument interface. All screws are manufactured from Ti-6AI-4V ELI alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
EQUIVALENCE TO MARKETED DEVICE
NEOORTHO Produtos Ortopédicos S/A submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K090047, Synthes (USA), Synthes (USA) 1.5 mm Mini Fragment LCP System K063049, Synthes (USA), Synthes (USA) Modular Mini Fragment LCP System
5
K102694, Synthes (USA), Synthes (USA) 2.4 mm Variable Angle LCP Dorsal Distal Radius Plates
K071184, Synthes (USA), Synthes Variable Angle-locking Compression Plate (VA-LCP) Distal Radius System
K083694, Synthes (USA), Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates
K091644, Synthes (USA), Synthes (USA) 2.4 mm LCP Volar Column Distal Radius Plates
K092556, Synthes (USA) 2.4 mm VA-LCP Two-Column Narrow Volar Distal Radius Plates
K012114, Synthes (USA), Synthes Locking Distal Radius Plating System
K102641, NEOORTHO Produtos Ortopédicos S/A, Mini and Micro Fragments Reconstruction System - NEOFACE
K982732, Synthes (USA), Synthes (USA) Distal Radius Plate System K113733, NEOORTHO Produtos Ortopédicos S/A, Small and Large Fragments Osteosynthesis System NEOFIX
The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials. The subject and predicate devices encompass the same range of physical dimensions, and share similar characteristics including locking and non-locking plate and screw designs. The subject and predicate devices are packaged using the same materials, and are to be sterilized by the same methods. Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject and predicate device designs, engineering analysis, and mechanical testing of the subject designs. Any differences in the technological characteristics do not raise new issues of safety or efficacy. All of the subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared predicate devices in K102641 and K113733, and therefore are substantially equivalent to the predicates with regard to materials and biocompatibility.
Overall, the subject device has the following similarities to the predicate devices:
- has the same intended use.
- uses the same operating principle, ●
- incorporates the same basic designs, ●
- incorporates the same or very similar materials, and
- has similar packaging and is to be sterilized using the same processes.