(320 days)
Not Found
No
The summary describes a system of bone nails and screws made of titanium, intended for fracture fixation. There is no mention of software, algorithms, image processing, or any other components that would suggest the use of AI or ML. The performance studies focus on material and mechanical standards.
Yes.
The device is intended to stabilize various types of bone fractures (tibia, femoral, humeral, etc.), treat non-unions, malunions, and impending pathologic fractures, which are all conditions requiring medical treatment or management.
No
Explanation: The Auxein Nailing system is used for stabilizing fractures and provides fixation for bones. It is a therapeutic device, not a diagnostic one, as it does not gather or analyze data to identify a medical condition.
No
The device description explicitly states that the device consists of various shapes and sizes of nails, screws, and end caps fabricated from titanium. These are physical hardware components, not software.
Based on the provided information, the Auxein Nailing System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the device is used to "stabilize fractures," "treat stable and unstable proximal fractures," "fixation of diaphyseal fractures," and "fixation of fractures." These are all procedures performed in vivo (within the living body) to treat bone fractures.
- Device Description: The device description details various types of nails, screws, and end caps made of titanium, designed for surgical implantation into bones. This aligns with the description of orthopedic implants used for fracture fixation.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Auxein Nailing System does not perform any such function. It is a surgical implant used directly on the patient's bone.
Therefore, the Auxein Nailing System is an orthopedic surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Device Name: Auxein Nailing System are categorized to the following system:
-
Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Ga-mma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System INDICATION FOR USE:
-
AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.
-
AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
-
AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
-
AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.
-
The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures .
-
AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
-
AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following turnor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
Product codes (comma separated list FDA assigned to the subject device)
HSB, JDS
Device Description
Auxein Nailing System is a line of bone nails and screws fabricated from titanium, categorized into several systems: Expert Tibia Nailing System, Expert Femoral Nailing System, Ga-mma Nailing System, AJAX Advance Nailing System, Elastic Nailing System, Humeral Nailing System, and Retrograde Nailing System. These systems include various shapes and sizes of nails with proximal and distal holes, end caps, locking bolts, inner screws, anti-rotation screws, compression screws, and cephalic screws.
For the Expert Tibia Nail system, nail diameters range from 8 mm to 12 mm and lengths from 255 mm to 375 mm. Screw implants are 4.4 mm & 4.8 mm in diameter, with lengths from 18 mm to 90 mm.
The Expert Femoral Nail system has nail diameters from 9 mm to 13 mm and lengths from 320 mm to 440 mm. Screw implants are 4.8 mm & 6.4 mm in diameter, with lengths from 25 mm to 130 mm.
The Ga-mma Nailing system includes nails with diameters from 9 mm to 13 mm and lengths from 180 mm to 440 mm. Screw implants are 4.8 mm, 6.4 mm & 10.5 mm in diameter, with lengths from 26 mm to 120 mm.
The Humeral Nailing system nails have diameters from 7 mm to 9 mm and lengths from 180 mm to 320 mm. Screw implants are 3.5 mm & 4.5 mm in diameter, with lengths from 20 mm to 70 mm.
The AJAX Advance Nailing system nails have diameters from 9 mm to 12 mm and lengths from 170 mm to 420 mm. Screw implants are 4.9 mm & 10.5 mm in diameter, with lengths from 26 mm to 120 mm.
The Elastic Nailing system nails have diameters from 1.5 mm to 4.0 mm and a total length of 440 mm. End caps have corresponding diameters and lengths of 14 mm & 25 mm.
The Retrograde Nailing system nails have diameters from 10 mm to 12 mm and lengths from 180 mm to 360 mm. Screw implants are 5.0 mm in diameter, with lengths from 32 mm to 80 mm.
All implants are sold non-sterile and require sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia, Femur, Humerus
Indicated Patient Age Range
Children above the age of 6 years and any patient below 65 kg (for Elastic Intramedullary Nail System). Other systems are not specified by age.
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 based on applicable product standards: Material Standards (ASTM F 136, ASTM F899-12b) and Performance Standards (ASTM F 1264, ASTM F 384, ASTM F 543). The report states that the purchased material compliance to these standards was verified, and device performance was demonstrated against the applicable standards.
Clinical evaluation/clinical equivalence was documented in section 11 as per MEDDEV2.71 REV.04: 2016 due to the device being of similar design, pattern, and intended use to predicate devices.
The conclusion is that the data completely supports the substantial equivalence of the Auxein brand of nailing system to the predicate devices listed based on similar product code, regulation number, regulatory class, intended use, sterilization method, mechanical test performance, and material standards.
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.
K962047, K000089, K040762, K040336, K100238, K012190, K970097, K131548, K032687, K120807, K033071, K051557
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 10, 2020
Auxein Medical Private Limited Rahul Luthra Director, Regulatory Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli Industrial area Sonepat, IN 131028 Haryana
Re: K192003
Trade/Device Name: Auxein Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, JDS Dated: April 23, 2020 Received: April 23, 2020
Dear Rahul Luthra:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Michael Owens Acting 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) K192003
Device Name Auxein Nailing system
Indications for Use (Describe)
Device Name: Auxein Nailing System are categorized to the following system:
-
Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Ga-mma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System INDICATION FOR USE:
-
AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.
-
AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
-
AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
-
AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.
-
The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures .
-
AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
-
AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following turnor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
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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Image /page/4/Picture/0 description: The image shows the text 'K192003' in a simple, sans-serif font. The text is presented in a single line, with each character clearly legible. The alphanumeric sequence appears to be a code or identifier, possibly a product or serial number.
Image /page/4/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
CORPORATE OFFICE:
7-A, Nirankari Colony,
Delhi-110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
+91 99106 43638
+91 86077 70197 (FAX)
.auxein.com
Section 5.0 - 510K Summary
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: | Auxein Medical Private Limited. |
|---|---|
| Address: | Auxein Medical Private Limited, |
| Plot Number 168-169-170, Phase-IV, | |
| Kundli Industrial Area, HSIIDC, Sector-57, | |
| Sonepat, Haryana – 131028, India | |
| Contact Person Name: | Mr. Rahul Luthra |
| Title: | Director |
| Phone Number: | +91-9811720999 |
| Dated: | 07.03.2020 |
Throughout the submission Auxein Brand of Nails are covered under this 510(k) submission.
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Image /page/5/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a sans-serif font. The logo is simple and modern.
7-A, Nirankari Colony,
Delhi - 110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
IIDC, Sonepat-131028, Haryana, India
+91 99106 43638
6077 70197 (FAX)
.auxein.com
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:
Auxein Nailing System
Common or Usual Name:
Rod, Fixation, Intramedullary and Accessories
Nail, Fixation, Bone
Classification Name:
Intramedullary Fixation Rod.
Single/multiple component metallic bone fixation appliances and accessories
Product Code:
HSB, JDS
Device Class: II
Review Panel: Orthopedic
Regulation Number: 21 CFR 888.3020, 21 CFR 888.3030
Variants/Types:
Auxein Nailing System is divided in following categories.
| S. No. | Name |
|---|---|
| 01 | Expert Tibia Nailing System |
| 02 | Expert Femoral Nailing System |
| 03 | Ga-mma Nailing System |
| 04 | AJAX Advance nailing system |
6
Image /page/6/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. The "A" in the circle is also stylized, with a curved line connecting the two sides of the letter.
CORPORATE OFFICE:
7-A, Nirankari Colony,
Delhi - 110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
Sonepat-131028, Haryana, India
+91 99106 43638
+91 86077 70197 (FAX)
.auxein.com
| 05 | Elastic Nailing System |
|---|---|
| 06 | Humeral Nailing System |
| 07 | Retrograde Nailing System |
The aforementioned Nails are used with End cap, locking bolt, Cannulated Anti-Rotation screw, proximal screw, Inner screw, compression screw and Cephalic Screw.
A.3) 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. | Item Description | Predicate Device |
|---|---|---|
| 1. | Expert Tibia Nail | K962047, SYNTHES (USA) TITANIUM CANNULATED TIBIAL NAIL (TI |
| CTN) | ||
| 2. | End cap for Expert Tibia Nail | |
| 3. | Ø 4.4 mm locking bolt | K000089,SYNTHES (USA), Locking screws |
| 4. | Ø 4.8 mm Locking bolt, self-tapping | K040762, SYNTHES (USA) TIBIAL NAIL SYSTEM EX |
| 5. | Expert Femoral Nail, Left | |
| 6. | Expert Femoral Nail, Right | K040336, SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM |
| 7. | Ø 6.4 mm Cannulated Anti-Rotation Screw, | |
| Self-Tapping for Expert Femoral Nail | ||
| 8. | End Cap for Expert Femoral Nail | |
| 9. | 130° Anti-Rotation Ga-mma Nail, Long, Left | K100238 DEPUY ORTHOPAEDICS, INC |
| 9. | 130° Anti-Rotation Ga-mma Nail, Long, | |
| Right | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, | |
| K012190, ADVANCED ORHTOPAEDIC SOLUTION, AOS Modular | ||
| Femoral Nail | ||
| 10. | 130° Anti-Rotation Ga-mma Nail, Short | |
| 11 | Inner Screw For Anti-Rotation Ga-mma Nail - Long | |
| 12 | Inner Screw For Anti-Rotation Ga-mma Nail - Short | K100238 DEPUY ORTHOPAEDICS, INC |
| HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, | ||
| 13 | Ø6.4mm Cannulated Anti-Rotation Screw | |
| 14 | 130° Ga-mma Nail Type-II, Short | |
| 15 | 130° Ga-mma Nail, Type-II, Long, Left | |
| 16 | 130° Ga-mma Nail, Type-II, Long, Right | |
| 17 | End Cap For Ga-mma Nail Type-II | |
| 18 | End Cap For Ø10.5mm Cephalic Screw For Ga-mma Nail | |
| 19 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mm Nail | K962047 SYNTHES (USA) TITANIUM CANNULATED TIBIAL NAIL (TI CTN) |
| 20 | Ø10.5mm Cephalic Screw For Ga-mma Nail | |
| 21 | Inner Screw For Ga-mma Nail Type-II | |
| 22 | 130° AJAX Advance Nail, Short, | |
| 23 | 130° AJAX Advance Nail, Long, Left | K100238 DEPUY ORTHOPAEDICS, INC |
| HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, | ||
| 24 | 130° AJAX Advance Nail, Long, Right | |
| 25 | 125° AJAX Advance Nail, Short, | |
| 26 | 125° AJAX Advance Nail, Long, Left | |
| 27 | 125° AJAX Advance Nail, Long, Right, | |
| 28 | AJAX Ø 4.9mm Locking Bolt, Self-Tapping | |
| 29 | Ajax Cephalic Screws | K970097, SYNTHES(USA) PROXIMAL FEMORAL NAIL (PFN) SYSTEM |
| K131548,SYNTHES (USA), Synthes Trochanteric Fixation Nail - | ||
| Advanced System, used as predicate for Ajax Cephalic screws | ||
| 30 | End Cap (For Cephalic Screws) | |
| 31 | Inner Screws for Ajax Cephalic Screws | |
| 32 | Ajax Nail end cap( for cephalic Screws) | |
| 33 | Titanium Elastic Nail | K032687 ACE NANCY NAIL DEPUY ORTHOPAEDICS, INC. 700 |
| ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 | ||
| 34 | End cap for Titanium Elastic Nail, Size- 1 | |
| 35 | End cap for Titanium Elastic Nail, Size- 2 | |
| 36 | Reconstruction Nail,Cannulated | |
| 37 | Ø 3.5mm Locking Bolt | |
| 38 | End Cap for Reconstruction cannulated | |
| intramedullary Humeral Nail | K120807, SYNTHES MULTILOC HUMERAL NAILING SYSTEM | |
| 39 | Reconstruction cannulated intramedullary | |
| Humeral Nail | ||
| 40 | 4.5 mm Locking Bolt for Intramedullary | |
| Cannulated Humeral Nail | ||
| 41 | 4.5 mm proximal Screw | |
| 42 | Intramedullary Cannulated Humeral Nail | |
| 43 | End Cap for Intramedullary Cannulated | |
| Humeral Nail | K033071,SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL | |
| SYSTEM | ||
| 44 | Compression Screw for Intramedullary | |
| Cannulated Humeral Nail | ||
| 45 | Retrograde Femoral Nail | K051557, SMITH & NEPHEW, INC TRIGEN RETROGRADE FEMORAL, |
| SUPRACONDYLAR AND TIBIAL NAILS | ||
| 46 | End Cap For Retrograde Femoral Nail | |
| 47 | 5.0 MM Locking Bolt Retrograde Nail |
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Image /page/7/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it. To the right of the circle is the word "Auxein" in blue, with the same font as the "A" in the circle.
CORPORATE OFFICE:
MANUFACTURING UNIT
Sector-Sector-Sector-Section
J +91 99106 43638
+91 86077 70197 (FAX)
8
Image /page/8/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
CORPORATE OFFICE:
MANUFACTURING UNIT
Sector-Sector-Sector-Section
+91 99106 43638
+91 86077 70197 (FAX) 8
9
Image /page/9/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a blue letter A inside of it. To the right of the circle is the word "Auxein" in blue.
CORPORATE OFFICE:
7-A, Nirankari Colony,
Delhi-110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
Sonepat-131028, Haryana, India
+91 99106 43638
+91 86077 70197 (FAX)
A.4). 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:
Nail Fixation
Auxein Brand of Expert Tibia Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & locking bolts of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 8 mm to 12 mm; the length varies from 255 mm to 375 mm.
The screw implants are in corresponding diameter of 4.4 mm & 4.8 mm diameters with lengths varying as per the requirements and minimum length: 18 mm to maximum length 90 mm.
Auxein Brand of Expert Femoral Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking screw & Anti-rotation screw of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
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Image /page/10/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized letter "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a serif font.
CORPORATE OFFICE:
7-A, Nirankari Colony,
Delhi - 110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
SIIDC, Sonepat-131028, Haryana, India
+010
The diameter of the nails varies from 9 mm to 13 mm; the length varies from 320 mm to 440 mm.
The screw implants are in corresponding diameter of 4.8 mm, 6.4 mm diameters with lengths varying as per the requirements and minimum length: 25 mm to maximum length 130 mm.
Auxein Brand of Ga-mma Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, Inner screw, locking bolts, Antirotation screw & Cephalic screw of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 9 mm to 13 mm; the length varies from 180 mm to 440 mm.
The screw implants are in corresponding diameter of 4.8 mm, 6.4mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm.
Auxein Brand of Humeral Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking bolt, compression screw, and proximal screw of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 7mm to 9 mm; the length varies from 180 mm to 320 mm.
The screw implants are in corresponding diameter of 3.5 mm & 4.5 mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 70mm.
Auxein Brand of AJAX Advance Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking bolts, Cephalic screw, inner screw of different sizes.
11
Image /page/11/Picture/0 description: The image shows the text "K192003" in a simple, sans-serif font. The text is black against a white background. The letters and numbers are evenly spaced and clearly legible.
Image /page/11/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it. To the right of the circle is the word "Auxein" in blue, sans-serif font.
7-A, Nirankari Colony,
Delhi-110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
SIIDC, Sonepat-131028, Haryana, India
+91 99106 43638
+91 86077 70197 (FAX)
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 9 mm to 12 mm; the length varies from 170 mmto 420 mm.
The screw implants are in corresponding diameter of 4.9 mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm.
Auxein Brand of Elastic Nailing system consists of various shape and sizes of nails featuring end cap of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 1.5 mm to 4.0 mm; the total length of 440 mm.
The end caps are in corresponding diameter ranges from 1.5 mm to 4.0 mm diameters with length of 14 mm & 25 mm.
Auxein Brand of Retrograde Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & locking bolts of different sizes.
The nails and screws are fabricated from titanium.
The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.
The diameter of the nails varies from 10 mm to 12 mm; the length varies from 180 mm to 360 mm.
The screw implants are in corresponding diameter of 5.0 mm diameters with lengths varying as per the requirements and minimum length: 32 mm to maximum length 80 mm.
12
Image /page/12/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized letter A inside of it. To the right of the circle is the word "Auxein" in blue, with a font that matches the letter A in the circle.
CORPORATE OFFICE:
7-A, Nirankari Colony,
Delhi - 110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
SIIDC, Sonepat-131028, Haryana, India
+91 99106 43638
+91 86077 70197 (FAX)
These implants are sold non-sterile, the products have to be sterilized prior to use.
A5). A statement of the intended use of the device
Indications for Use:
- . AUXEIN Brand of Expert Tibia Nailing System- AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and distal tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.
- AUXEIN Brand of Expert Femoral Nailing System Expert Femoral Nail is ● intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
- AUXEIN Brand of Ga-mma Nailing System The Gamma Nail with Anti-Rotation ● Screw is intended to treat stable and unstable proximal fractures of the femur including per trochanteric fractures, intertrochanteric fractures, high sub trochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat per trochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long sub trochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
- AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended ● to treat stable and unstable proximal femoral fracture including Per trochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fracture.
- The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is important. This includes upper extremity fractures in all patients and lower extremity fractures in children
13
Image /page/13/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. The font is sans-serif and the overall design is simple and modern.
CORPORATE OFFICE:
7-A, Nirankari Colony,
Delhi - 110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
SIIDC, Sonepat-131028, Haryana, India
+91 99106 43638
+91 86077 70197 (FAX)
.auxein.com
above the age of 6 years and any patient below 65 kg. This system is also intended to trea metaphyseal and epiphyseal fractures, such as radial neck fractures.
- AUXEIN Brand of Humeral Nailing System This Nail indicated for fractures of . the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
- AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple ● long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures: reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
A.6). Summary of Technological Characteristics as compared to the predicate devices:
Substantial equivalence including comparison with predicate devices
A comparison between the Auxein Brand of Nails, screws, and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.
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Image /page/14/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
.auxein.com
Following is the summary of parameters in which the comparison has been verified:
| S. No. | Characteristics | Predicate Device Versus New
Device (Auxein Brand) | Remarks |
|--------|-----------------------------|----------------------------------------------------------------------------------------|------------|
| 01 | Indications for use | Similar intended use in New Device
and Predicate device | Equivalent |
| 02 | Material | Same material used in New Device
and Predicate device | Equivalent |
| 03 | Performance
Standards | Same performance standards used in
both New Device as well as predicate
device | Equivalent |
| 04 | Sterilization | Same method of sterilization used in
both New Device as well as
Predicate device | Equivalent |
| 05 | Dimensional
Verification | Similar dimensions found in both
New Device as well as Predicate
device | Equivalent |
B.1). 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 with following material standards
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Image /page/15/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. The font is sans-serif and the overall design is simple and modern.
CORPORATE OFFICE:
7-A, Nirankari Colony,
Delhi-110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
SIIDC, Sonepat-131028, Haryana, India
+91 99106 43638
+91 86077 70197 (FAX)
-
- ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
- 2 ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments.
We have verified the purchased material compliance to these standards and copies of the relevant test results is attached herewith
B: Performance Standards:
The device performance of Auxein Brand of Nails, screws, has been demonstrated against following applicable standards
- ASTM F 1264 .
- . ASTM F 384
- ASTM F 543 .
- B.2). Discussion on the clinical evaluation referenced and relied upon: .
Auxein Brand of devices is of similar design and pattern as well as similar intended use. Under such situation we have also considered the meddev guidance document MEDDEV2.71 REV.04: 2016 and as per that clinical evaluation / clinical equivalence has been documented in section 11.
CONCLUSION:
General, Safety and Performance conclusion:
| S. No. | Parameter of
Conclusion | Proposed Device | Predicate
Device |
|--------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 01 | Product Code | HSB
JDS | Same |
| 02 | Regulation
Number | 21 CFR 888.3020
21 CFR 888.3030 | Same |
| 03 | Regulatory
Class | Class II | Same |
| 04 | Intended Use | AUXEIN Brand of Expert Tibia Nailing
System- consists of variety of Bone nails
and bone screws. Expert Tibia Nail System
is intended to stabilize fractures of the
proximal and distal tibia and the tibial shaft;
open and closed tibial shaft fractures;
certain pre and post-isthmic fractures; and
tibial malunions and non- unions. Auxein Brand of Expert Femoral Nailing
System - Expert Femoral Nail is intended to
stabilize femoral shaft fractures, sub
trochanteric fractures, ipsilateral neck/shaft
fractures, impending pathologic fractures,
non-unions and malunions. Auxein Brand Gamma Nailing system - The
Gamma Nail with Anti-Rotation Screw is
intended to treat stable and unstable proximal
fractures of the femur including per trochanteric
fractures, intertrochanteric fractures, high sub
trochanteric fractures and combinations of these
fractures, including non-union, malunion and
tumor resections. The Long Nail system is
additionally indicated to treat per trochanteric
fractures associated with shaft fractures,
pathologic fractures in osteoporotic bone
(including prophylactic use) of the trochanteric
and diaphyseal areas, impending pathological
fractures, long sub trochanteric fractures,
ipsilateral femoral fractures, proximal or distal
non-unions, malunions, revision procedures and
tumor resections. | Similar
Intended
Use |
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Image /page/16/Picture/0 description: The image shows the word "Auxein" in blue font. To the left of the word is a blue circle with a stylized letter "A" inside. The letter "A" is also in blue and has a similar font to the word "Auxein". The background of the image is white.
CORPORATE OFFFICE: O
7-A, Nirankari Colony,
Delhi - 110 009, India MANUFACTURING UNIT
Sector-Sector-Sector-Section
+91 99106 43638
+91 86077 70197 (FAX)
J
17
Image /page/17/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
CORPORATE OFFICE:
MANUFACTURING UNIT
+91 99106 43638
+91 86077 70197 (FAX)
2
| Auxein Brand of AJAX Advance Nailing System , end cap and screws is intended to treat stable and unstable proximal femoral fracture including Per trochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fracture. |
|---|
| The AUXEIN MEDICAL'S Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures. |
| AUXEIN Brand of Humeral Nailing System |
- This Nail indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures. |
18
Image /page/18/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. The font is sans-serif and the logo is simple and modern.
CORPORATE OFFICE:
MANUFACTURING UNIT
Sector-Sector-Sector-Section
+91 99106 43638
+91 86077 70197 (FAX)
8
| AUXEIN Brand of Retrograde Nailing System - This nail are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated. |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
19
Image /page/19/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized letter "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a font that is similar to Times New Roman.
Image /page/19/Picture/1 description: The image shows contact information for a company. The corporate office is located at 7-A, Nirankari Colony, Delhi - 110 009, India. The manufacturing unit is located at Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, Sonepat-131028, Haryana, India. The phone number is +91 99106 43638 and the fax number is +91 86077 70197.
| 05 | Sterilization | Provided Non-Sterile and to be sterilized using
Autoclaving Method to achieve SAL of 10-6 | Same |
|----|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 06 | Mechanical
Test
Performance | For Nails & Screws:
As per ASTM F 1264,ASTM F 384,ASTM F 543
Standard Specification and Test Methods for
Intramedullary Fixation Devices | Same |
| 07 | Material
Standards | ASTM F 136 & ASTM F 899-12b | Same |
The data described above completely supports the substantial equivalence of the Auxein brand of nailing system to the predicate devices listed.