(108 days)
Not Found
No
The device description focuses solely on the physical components (plates, screws) and materials used for fracture fixation. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes.
The device is intended for fracture fixation, arthrodesis, and osteotomy fixation, which are therapeutic interventions.
No
This device is described as an "Osteosynthesis System" intended for "bone fracture fixation, arthrodesis and osteotomy fixation," which are surgical treatment procedures, not diagnostic activities. The device comprises plates and screws used to physically fix bones.
No
The device description explicitly states it consists of plates and screws made from titanium or stainless steel, which are hardware components.
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 "small and large bone fracture fixation, arthrodesis and osteotomy fixation." This describes a surgical implant used to physically stabilize bones.
- Device Description: The description details plates and screws made of titanium or stainless steel, designed for surgical implantation.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
NMUC Brand Small and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.
NMUC Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric or intertrochanteric zones. The system is indicated for use in adult patients only. All implants are for single use only
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
NMUC brand small fragment and large fragment Osteosynthesis plating system consists of plates and screws in a variety of designs and made from Ti-6AI-4V (Titanium) alloy or stainless steel. Plates are provided in a straight design also in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screw designs. Screws are provided in, 3.5mm cortex self-tapping, 4.5 mm diameter cortex self-tapping and 2.7mm diameter self-tapping cortex locking, 3.5mm self-tapping cortex locking, 5.0mm cortex locking thread designs in various lengths.
DHS/DCS, systems are made from Ti-6AI-4V (Titanium) alloy or stainless steel and consists of DHS/DCS plates, lag screws, compression screws and 4.5mm diameter cortex screw selftapping. The plates are available with barrel length 25mm and 38 mm with angles variances between 130° to 150°. The DCS plate have angles of 95°.
The products are provided NON-STERILE only. Subsequent of being sold as NON-STERILE product, the intention is to achieve sterility by utilizing autoclaving method on parameters of SAL10-6 AAMI ST79 & ISO 17665-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, tibial pilon, fibula, pelvis and acetabulum, femoral neck, trochanteric, pertrochanteric or intertrochanteric zones of the proximal femur. (Not indicated for use in the spine)
Indicated Patient Age Range
adult patients only
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)
All devices stated herein undergo the same manufacturing, testing and qualification methods as the predicate devices. Related specifications and standards in which device were tested to are below:
-
- ASTM F136 Standard specification for wrought titanium
-
- ASTM F138 Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel
-
- ASTM F139 Standard specification for wrought stainless steel sheet and strip for surgical implants
The information included in this submission demonstrates substantial equivalence. No performance testing was included in this submission.
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
§ 888.3030 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
Narang Medical USA Corporation Mr. Reginald Swift Ouality/Regulatory Director 15951 SW 41 St Suite 800b Davie, FL 33331
Re: K163425 Trade/Device Name: NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System 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: February 24, 2017 Received: February 24, 2017
Dear Mr. Swift:
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 (reporting of medical device
1
related 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163425
Device Name
NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System
Indications for Use (Describe)
NMUC Brand Small and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, tibial pilon, fibula, pelvis and acetabulum fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.
NMUC Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric, pertrochanteric or intertrochanteric zones. The system is in adult patients only. All implants are for single use only
| 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/20 description: The image shows a logo with the letters "NET" in a bold, sans-serif font. The letters are arranged vertically, with the "N" on top, the "E" in the middle, and the "T" on the bottom. The letters are black and are set against a white background. The entire logo is enclosed in a blue circle. A small "R" in a circle, indicating a registered trademark, is located in the upper right corner of the blue circle.
K163425 Page 1 of 3
NARANG MEDICAL USA CORPORATION
510(k) Summary
Date : 1/25/17
Registration Number: 3012544669
Submitted by: Narang Medical USA Corporation 15951 SW 41 St Suite 800b Davie, FL 33331
Contact Person: Reginald Swift Quality/Regulatory Director Narang Medical USA Corporation reggie@narang.com
510(k) Number: K163425
This is a bundled submission that includes devices that are used for the same orthopedic region(s).
Primary Predicate: K150561
Proprietary Name(s):
- NMUC Brand Small and Large Fragment Osteosynthesis Plating System ●
- NMUC Brand of DHS/DCS Plating System ●
Common Name:
- Orthopedic Bone Plates ●
- Orthopedic Bone Screws ●
Classification & Product Code References:
- Class II
- HRS Plate, Fixation, Bone (21 CFR 888.3030) ●
- HWC Screw, Fixation, Bone (21 CFR 888.3040) o
Device Description:
4
NMUC brand small fragment and large fragment Osteosynthesis plating system consists of plates and screws in a variety of designs and made from Ti-6AI-4V (Titanium) alloy or stainless steel. Plates are provided in a straight design also in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screw designs. Screws are provided in, 3.5mm cortex self-tapping, 4.5 mm diameter cortex self-tapping and 2.7mm diameter self-tapping cortex locking, 3.5mm self-tapping cortex locking, 5.0mm cortex locking thread designs in various lengths.
DHS/DCS, systems are made from Ti-6AI-4V (Titanium) alloy or stainless steel and consists of DHS/DCS plates, lag screws, compression screws and 4.5mm diameter cortex screw selftapping. The plates are available with barrel length 25mm and 38 mm with angles variances between 130° to 150°. The DCS plate have angles of 95°.
The products are provided NON-STERILE only. Subsequent of being sold as NON-STERILE product, the intention is to achieve sterility by utilizing autoclaving method on parameters of SAL10-6 AAMI ST79 & ISO 17665-1.
Intended / Indications for Use:
NMUC Brand Small Fragment and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.
NMUC Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric or intertrochanteric zones. The system is indicated for use in adult patients only. All implants are for single use only
Technoloqical Characteristics:
Equivalence is concretely supported in its comparison as being the exact same device as noted in the substantial equivalence portion of this document and cleared under cited 510(k) clearance. Comparison between noted devices and predicates are exactly the same under all regards in its intended use, packaging, labeling, materials and design of the product.
Substantial Equivalence:
- The components and assemblies of this device are substantially equivalent to the ● following:
5
| 510(k) Number | Company | Product | Reference to
(Company
Product) |
|---------------|--------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| K150561 | Narang Medical Ltd | NET brand Small
and large fragment
Osteosynthesis
family plating
system | NMUC branded
small and large
Osteosynthesis
family system |
| K150561 | Narang Medical Ltd | NET brand
DHS/DCS family
plating system | NMUC branded
DHS/DCS family
plating system |
- o Equivalence is based on similarities in intended use, materials and design to the predicate devices demonstrating substantial equivalence to the predicate devices
- Prior submission related to devices substantial equivalence (exclusive to products ● examined under submission) summary has been based from 510(k) number: K150561 under Narang Medical Limited in which is the manufacturer of the devices for Narang Medical USA Corporation.
- o Legally marketed statement: all devices that belong to the families of devices contained within both system of devices are legally marketed as Narang Medical Limited company devices (proved under submission K150561). All critical features including: intended surgical use, safety and efficacy, and technical features of the devices remain unchanged as only the labeling of the devices shall now only correspond to Narang Medical USA corporation as the company to legally market these family of devices (under submission K163425).
Performance Data:
All devices stated herein undergo the same manufacturing, testing and qualification methods as the predicate devices. Related specifications and standards in which device were tested to are below:
-
- ASTM F136 Standard specification for wrought titanium
-
- ASTM F138 Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless steel
-
- ASTM F139 Standard specification for wrought stainless steel sheet and strip for surgical implants
The information included in this submission demonstrates substantial equivalence. No performance testing was included in this submission.