(146 days)
No
The summary describes a system of physical implants (nails, screws, bolts) for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical testing of the physical devices.
No
This device is an osteosynthesis nailing system used for stabilizing bone fractures, which is a structural implant rather than a therapeutic device that administers therapy or treatment.
No
The device, an osteosynthesis nailing system, is intended for stabilization of fractures, non-unions, and malunions, which are treatment functions rather than diagnostic ones.
No
The device description explicitly states it consists of various shapes and sizes of Nails, Screws, and Locking Bolts fabricated from Stainless Steel and Titanium, which are physical 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 device is intended for the stabilization and fixation of bone fractures (tibial and femoral shaft, subtrochanteric, etc.). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of physical implants (nails, screws, locking bolts) made of stainless steel and titanium, designed to be surgically inserted into bone.
- Lack of Diagnostic Purpose: The description does not mention any function related to analyzing samples from the human body (blood, urine, tissue, etc.) to provide diagnostic information.
- Anatomical Site: The device is used within the musculoskeletal system (bones).
- Performance Studies: The performance studies focus on the mechanical properties of the implants (bending, torsion, fatigue, pull-out), which are relevant to their function as surgical implants, not diagnostic tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a physical condition (fractures).
N/A
Intended Use / Indications for Use
NET BRAND Osteosynthesis Nailing System are provided non-sterile.
Tibial Nails are indicated for stabilization of fractures of proximal and distal tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions.
Femoral Nails are indicated for stabilization of femoral shaft fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
The Elastic Nails are indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or the flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients. In paediatic applications, the elastic intramedullary nailing allows it to be inserted at a point which avoids disruption of the bone growth plate. All Implants are for single use only.
Product codes
JDS, HSB, HWC, HTY
Device Description
NET BRAND Osteosynthesis Nailing System consists of various shape and sizes of Nails and Screws, Locking Bolts.
The NET BRAND Osteosynthesis Nailing System are fabricated from Stainless Steel And Titanium.
The system contains several models based on the size of the device and application site such as fixation/reconstruction of Tibia and Femoral bones appropriate for the device. The Nail implants are available in many diameters and lengths.
These all are mainly divided into
- Tibia Nail
- Femoral Nail
- Elastic Nail
- Corresponding Screws and Locking Bolts for Fixations of These Nails.
These implants are supplied non-sterile, the products have to be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial shaft, femoral shaft, long bones (upper extremity, lower extremity).
Indicated Patient Age Range
paediatric or small statured patients for lower extremity fractures (Elastic Nails). 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)
Non-clinical testing was performed against applicable product standards.
Study type: Side-by-Side testing was performed for Static Four Point Bend Test, Static Torsional Properties, Bending Fatique Properties, Static Compression Bend Test for Bone Nails and Torsional Properties, Driving Torque, Pull-out Test for Bone Screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SYNTHES Titanium Tibia Nail (K914453), SYNTHES Titanium Tibia Nail (K962047), SYNTHES (USA) UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL (K914453), SYNTHES Lateral Entry Femoral Nail (K040336), SYNTHES Cannulated Femoral Nail (K954856), SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM (K011857), Synthes Elastic Intramedullary nailing System (K971783)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
February 20, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Narang Medical LTD. Vivek Narang Director Narang Tower, 46, Community Center, Naraina, Phase -1 Delhi. New Delhi 110028 India
Re: K233150
Trade/Device Name: NET BRAND Osteosynthesis Nailing System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDS, HSB, HWC, HTY Dated: January 16, 2024 Received: January 16, 2024
Dear Vivek Narang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/6 description: The image shows the name "Joseph P. Russell" in a large, clear font. Below the name, there is a signature or initial represented by "-S". To the right, the text "Digitally Russell Date:" is visible, followed by "-05'00'", which likely indicates a timestamp or time zone.
Digitally signed by Joseph P. Russell -S Date: 2024.02.20 11:32:39
for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K233150
Device Name NET BRAND Osteosynthesis Nailing System
Indications for Use (Describe)
NET BRAND Osteosynthesis Nailing System are provided non-sterile.
Tibial Nails are indicated for stabilization of fractures of proximal and distal tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions.
Femoral Nails are indicated for stabilization of femoral shaft fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
The Elastic Nalls are indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or the flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients. In paediatic applications, the elastic intramedullary nailing allows it to be inserted at a point which avoids disruption of the bone growth plate. All Implants are for single use only.
| 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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3
Premarket Notification 510(k) Summary as required by Section 807.92
General Company Information as required by 807:92 (a)
(a.1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared.
| Submitter's Name: | NARANG MEDICAL LTD. |
|---|---|
| Address: | Office: |
| Narang Tower, 46, Community Center, Naraina, Phase -1, New Delhi- | |
| 110028, India. |
Factory:
Plot Number: D-4, Sector A-2 Tronica City, Loni, Ghaziabad, Uttar
Pradesh, 201102 India |
| Contact Person Name: | Vivek Narang |
| Title: | Director |
| Phone Number: | +91 11 45554000, +91 9810738300 |
| Dated: | 21-09-2023 |
This is a bundled submission.
Throughout the submission there is a mention of NET BRAND Osteosynthesis Nailing System that represents the range of products covered under this 510(k) submission.
4
a.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
Proprietary Name:
- . NET BRAND Osteosynthesis Nailing System
Common or Usual Name:
- Orthopaedic Bone Nail
- Orthopaedic Bone Screw
Classification Name:
- · Intramedullary fixation rod
- · Smooth or threaded metallic bone fixation fastener
- Single/multiple component metallic bone fixation appliances and accessories
Product Code:
JDS, HSB, HWC, HTY
Device Class: Il
Review Name: Orthopaedic
Regulation Number: 21 CFR 888.3020, 21 CFR 888.3030 and 21 CFR 888.3040
Variants/Types:
NET BRAND Osteosynthesis Nailing System are further subdivided into following categories
| S. No. | Category | Types |
|---|---|---|
| 01 | Tibia Nail | Cannulated, Unreamed and Universsal Long Bend Type |
| 02 | Femoral Nail | Cannulated Long, Cannulated Short, Antirotation Long, |
| Antirotation Short | ||
| 03 | Elastic Nail | Diameters: 2.0, 2.5, 3.0, 3.5, 4.0mm (Length 440mm) |
| 04 | Bone Screws | Ø4.8mm Cancellous Locking Screw (Dual Core) |
| Locking screws for Perfect Tibial Nails, 4.35mm and 4.8mm" | ||
| Hip Screws, Ø6.35mm for Perfect Femoral Nail | ||
| Locking Bolt, Ø4.5mm (Self Tapping) | ||
| Locking Bolt, Ø 6.0mm (Self Tapping) | ||
| Locking Bolt, Ø 4.9 mm (Self Tapping) | ||
| PFNA-II Nail Blade Screw (Cannulated) | ||
| S. No. | Category | Types |
| 01 | Tibia Nail | Perfect Tibial Nails – Cannulated, |
| Multi-Fix Tibial Nail - Cannulated (Dynamic Hole), | ||
| Multi-Fix Tibial Nail - Unreamed (Dynamic Hole) | ||
| Easy Universal Tibial Nail Long Bend - Standard Distal Holes | ||
| 02 | Femoral Nail | Perfect Femoral Nail - Cannulated (Long) for Right and Left Leg |
| Perfect Femoral Nail - Cannulated (Short) | ||
| PFNA-II. Proximal Femoral Nail, Antirotation – Short | ||
| PFNA-II. Proximal Femoral Nail, Antirotation - Long (Left/Right) | ||
| 03 | Elastic Nail | Ø2.0mm x Length 44cm |
| Ø2.5mm x Length 44cm | ||
| Ø3.0mm x Length 44cm | ||
| Ø3.5mm x Length 44cm | ||
| Ø4.0mm x Length 44cm | ||
| 04 | Screws and Locking Bolts | Ø4.8mm Cancellous Locking Screw (Dual Core) for Perfect Tibial Nails |
| Locking Screws, Ø4.8mm for Perfect Tibial Nails | ||
| Locking Screws, Ø4.35mm for Perfect Tibial Nails | ||
| Hip Screws, Ø6.35mm for Perfect Femoral Nails | ||
| Locking Bolt, Ø4.5mm (Self Tapping) for Multi-Fix Nail | ||
| Locking Bolt, Ø 6.0mm (Self Tapping) for Multi-Fix Nail | ||
| PFNA-II Nail Locking Bolt, Ø 4.9 mm (Self Tapping) | ||
| PFNA-II Nail Blade Screw (Cannulated) |
5
Further Description of NET BRAND Osteosynthesis Nailing System.
Generally there are following types of Bone Nail used with Locking Screws and Locking Bolts. These Bone Nails are generally designed on the basis of the bone Tibia and Femur.
6
A3) Identification of the Predicate Device:
Following are the predicate device 510(k) with which we are declaring substantial equivalence:
Following is the range of variants covered with their corresponding predicate devices.
| S. No. | Subject Device | Corresponding Locking
Screws and End Caps | Predicate Device | S.
No. | Type of Device | Range of
Diameter | Range of
Length |
|--------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------|-----------------------------------------------------------------------------------|--------------------------------------------|--------------------|
| 1. | Perfect Tibial Nails -
Cannulated | Ø4.8mm Cancellous
Locking Screw (Dual
Core) for Perfect Tibial
Nails
Locking Screw, Ø4.35mm
for Perfect Tibial Nails
Locking Screws, Ø4.8mm
for Perfect Tibial Nails | SYNTHES Titanium Tibia Nail
(K914453) | 01. | Perfect Tibial Nails - Cannulated | 08mm to 13mm | 255mm to 465mm |
| 2. | Multi-Fix Tibial Nail -
Cannulated (Dynamic Hole) | Locking Bolt, Ø4.5mm
(Self Tapping) for Multi-
Fix Nail
Locking Bolt, Ø 6mm
(Self Tapping) for Multi-
Fix Nail | SYNTHES Titanium Tibia Nail
(K962047) | 02. | Multi-Fix Tibial Nail - Cannulated (Dynamic Hole) | 09mm to 13mm | 260mm to 430mm |
| 3. | Multi-Fix Tibial Nail - Unreamed
(Dynamic Hole) | Locking Bolt, Ø4.5mm
(Self Tapping) for Multi-
Fix Nail
Locking Bolt, Ø 6mm
(Self Tapping) for Multi-
Fix Nail | SYNTHES Titanium Tibia Nail
(K914453) | 03. | Multi-Fix Tibial Nail - Unreamed (Dynamic Hole) | 08mm to 9mm | 260mm to 440mm |
| 4. | Easy Universal Tibial Nail Long
Bend - Standard Distal Holes | Ø4.8mm Cancellous
Locking Screw (Dual
Core) for Perfect Tibial
Nails
Locking Screw, Ø4.35mm
for Perfect Tibial Nails
Locking Screws, Ø4.8mm
for Perfect Tibial Nails | SYNTHES (USA) UNIVERSAL
TIBIAL NAIL AND UNREAMED
TIBIAL NAIL (K914453) | 04. | Easy Universal Tibial Nail Long Bend - Standard
Distal Holes | 09mm to 12mm | 270mm to 380mm |
| 5. | Perfect Femoral Nail -
Cannulated (Long) for Right
and Left Leg | Locking Bolt 6.0mm (Self
Tapping)
Locking Bolt 4.9mm (Self
Tapping)
Hip Screws, Ø6.35mm for
Perfect Femoral Nails | SYNTHES Lateral Entry
Femoral Nail (K040336) | 05. | Perfect Femoral Nail - Cannulated (Long) for
Right and Left Leg | 09mm to 13mm | 320mm to 480mm |
| 6. | Perfect Femoral Nail -
Cannulated (Short) | Locking Bolt 6.0mm (Self
Tapping)
Locking Bolt 4.9mm (Self
Tapping)
Hip Screws, Ø6.35mm for
Perfect Femoral Nails | SYNTHES Cannulated Femoral
Nail (K954856) | 06. | Perfect Femoral Nail - Cannulated (Short) | 09mm to 13mm | 180mm to 240mm |
| 7. | PFNA-II. Proximal Femoral
Nail, Antirotation – Short | PFNA-II Nail Locking
Bolt, Ø 4.9 mm (Self
Tapping)
PFNA-II Nail Blade Screw
(Cannulated) | SYNTHES TROCHANTERIC
FIXATION NAIL (TFN) SYSTEM
(K011857 & K070294) | 07. | PFNA-II. Proximal Femoral Nail, Antirotation -
Short 125degree and 130 degree | 09mm to 12mm | 170mm to 240mm |
| | | | | 08. | PFNA-II. Proximal Femoral Nail, Antirotation -
Long (Left/Right) 125° and 130° | 09mm to 10mm | 260mm to 420mm |
| 8. | PFNA-II. Proximal Femoral
Nail, Antirotation - Long
(Left/Right) | PFNA-II Nail Locking
Bolt, Ø 4.9 mm (Self
Tapping)
PFNA-II Nail Blade Screw
(Cannulated) | SYNTHES TROCHANTERIC
FIXATION NAIL (TFN) SYSTEM
(K011857) | 09. | Elastic Nail | Diameters: 2.0,
2.5, 3.0, 3.5,
4.0mm | 440mm |
| 9. | Elastic Nail | Not Applicable | Synthes Elastic Intramedullary
nailing System (K971783) and
Depuy Ace Nancy Nail
(K032687) | 10. | Ø4.8mm Cancellous Locking Screw (Dual Core)
for Perfect Tibial Nails | Ø4.8mm | 25mm to 80mm |
| 10. | Ø4.8mm Cancellous Locking
Screw (Dual Core) for Perfect
Tibial Nails | Not Applicable | SYNTHES Titanium Tibia Nail
(K914453) | 11. | Locking Screw, Ø4.35mm for Perfect Tibial Nails | Ø4.35mm | 18mm to 80mm |
| 11. | Locking Screw, Ø4.35mm for
Perfect Tibial Nails | Not Applicable | SYNTHES Titanium Tibia Nail
(K914453) | 12. | Locking Screws, Ø4.8mm for Perfect Tibial Nails | Ø4.8mm | 26mm to 85mm |
| 12. | Locking Screws, Ø4.8mm for
Perfect Tibial Nails | Not Applicable | SYNTHES Titanium Tibia Nail
(K914453) | 13. | Hip Screws, Ø6.35mm for Perfect Femoral Nails | Ø6.35mm | 60mm to 115mm |
| 13. | Hip Screws, Ø6.35mm for
Perfect Femoral Nails | Not Applicable | SYNTHES Titanium Tibia Nail
(K914453) | 14. | Locking Bolt, Ø4.5mm (Self Tapping) for Multi-Fix
Nail | Ø4.5mm | 26mm to 80mm |
| 14. | Locking Bolt, Ø4.5mm (Self
Tapping) for Multi-Fix Nail | Not Applicable | SYNTHES Titanium Tibia Nail
(K962047) | 15. | Locking Bolt, Ø 6.0mm (Self Tapping) for Multi-
Fix Nail | Ø6.0mm | 30mm to 90mm |
| 15. | Locking Bolt, Ø 6mm (Self
Tapping) for Multi-Fix Nail | Not Applicable | SYNTHES Titanium Tibia Nail
(K962047) | 16. | PFNA-II Nail Locking Bolt, Ø 4.9 mm (Self
Tapping) | Ø4.9mm | 24mm to 100mm |
| 16. | PFNA-II Nail Locking Bolt, Ø
4.9 mm (Self Tapping) | Not Applicable | SYNTHES TROCHANTERIC
FIXATION NAIL (TFN) SYSTEM
(K011857) | 17. | PFNA-II Nail Blade Screw (Cannulated) | 12.0mm | 75mm to 120mm |
| 17. | PFNA-II Nail Blade Screw
(Cannulated) | Not Applicable | SYNTHES TROCHANTERIC
FIXATION NAIL (TFN) SYSTEM
(K011857) & K070294 | | | | |
7
a4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device
Device Description:
NET BRAND Osteosynthesis Nailing System consists of various shape and sizes of Nails and Screws, Locking Bolts.
The NET BRAND Osteosynthesis Nailing System are fabricated from Stainless Steel And Titanium.
The system contains several models based on the size of the device and application site such as fixation/reconstruction of Tibia and Femoral bones appropriate for the device. The Nail implants are available in many diameters and lengths.
These all are mainly divided into
- Tibia Nail ●
- Femoral Nail ●
- Elastic Nail
- . Corresponding Screws and Locking Bolts for Fixations of These Nails.
8
These implants are supplied non-sterile, the products have to be sterilized prior to use.
A5). A statement of the intended use of the device
Indications for Use:
• NET BRAND Osteosynthesis Nailing System are provided non-sterile.
9
Tibial Nails are indicated for stabilization of fractures of proximal and distal tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions.
Femoral Nails are indicated for stabilization of femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
The Elastic Nails are indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or the flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients, the flexibility of the elastic intramedullary nailing allows it to be inserted at a point which avoids disruption of the bone growth plate.
All Implants are for single use only.
a6). Summary of Technological Characteristics as compared to the predicate devices:
Substantial equivalence including comparison with predicate devices
A comparison between the NET BRAND Osteosynthesis Nailing System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
| S. No. | Characteristics | Predicate Device Versus Subject
Device (NET Brand) | Remarks |
|--------|-----------------------------|--------------------------------------------------------------------------------------|------------|
| 01 | Indications for
use | Similar intended use in Subject Device and Predicate device | Equivalent |
| 02 | Material | Same material used in Subject Device and Predicate device | Equivalent |
| 03 | Performance
Standards | Same performance standards used in both Subject Device as well as predicate device | Equivalent |
| 04 | Sterilization | Same method of sterilization used in both Subject Device as well as Predicate device | Equivalent |
| 05 | Dimensional
Verification | Similar dimensions found in both Subject
Device as well as Predicate device | Equivalent |
Following is the summary of parameters in which the comparison has been verified:
b1). Discussion on the non-clinical testing performed
Following are the applicable product standards considered for non-clinical standards
A: Material Standards
B: Performance Standards
A: Material Standards:
The material standards are the essential part to be complied to first, as it is the basis of manufacturing metallic surgical implants.
We have complied to following material standards
- ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
10
NARANG MEDICAL
- ASTM F 139: Standard Specification for Wrought 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surqical Implants
B: Performance Standards:
The device performance of NET BRAND Osteosynthesis Nailing System has been demonstrated against following applicable standards
For Bone Nail:
As per ASTM F 1264 Static Four Point Bend Test: Side-by-Side testing was performed Static Torsional Properties: Side-by-Side testing was performed Bending Fatique Properties: Side-by-Side testing was performed and ASTM F 384 Static Compression Bend Test: Side-by-Side testing was performed Bending Fatigue Properties; Side-by-Side testing was performed
For Bone Screws:
As per ASTM F 543 :Torsional Properties: Side-by-Side testing was performed. Driving Torque : Side-by-Side testing was performed, Pull-out Test: Side-by-Side testing was performed.
b2). Discussion on the clinical evaluation referenced and relied upon:
NET BRAND Osteosynthesis Nailing System are of similar design and pattern as well as same intended use. Clinical information was not necessary to demonstrate substantial equivalence. CONCLUSION:
General, Safety and Performance conclusion:
From the available data available we can justify that the NET BRAND Osteosynthesis Nailing System are as safe, and effective and perform as same indications for use as that of already marketed predicate devices identified in Section A3 of this 510(k) Summary.