(163 days)
HSB, JDS
No
The device description and intended use are focused on the mechanical properties and application of intramedullary nails and associated hardware for fracture fixation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
This device is intended to stabilize fractures, non-unions, and malunions, which are conditions that require treatment to restore proper anatomical function, aligning with the definition of a therapeutic device.
No
This device is an intramedullary nailing system intended to stabilize fractures of long bones. It is a surgical implant used for treatment, not for diagnosing medical conditions.
No
The device description explicitly states that the device is a metal rod (intramedullary nail) made from titanium alloy, along with associated screws and instruments. This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used to stabilize and treat fractures of various long bones (tibia, femur, humerus). This is a surgical intervention performed directly on the patient's body.
- Device Description: The device is described as a metal rod (intramedullary nail) made of titanium alloy, designed to be inserted into the bone's medullary cavity. This is a physical implant used for structural support.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the Auxein Nailing System does not involve any testing of biological samples.
- Performance Studies: The performance studies mentioned are related to mechanical testing and sterilization validation, which are relevant for surgical implants, not IVDs.
In summary, the Auxein Nailing System is a surgical implant used for orthopedic procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Device Name: Auxein Nailing System are categorized to the following system:
- Expert Tibia Nailing System
- Expert Femoral Nailing System
- Gamma Nailing System
- AJAX Advance nailing system
- Elastic Nailing System
- Humeral Nailing System
- 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 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 -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 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 tumor 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
An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body.
The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).
Auxein Brand of Expert Tibia Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & 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 8mm to 12mm; the length varies from 255mm. The screw implants are in corresponding diameter of 4.4mm & 4.8mm diameters with lengths varying as per the requirements and minimum length: 24mm to maximum length 90mm.
Auxein Brand of Expert Femoral Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, 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.The diameter of the nails varies from 9mm to 13mm; the length varies from 320mm to 440
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Auxein Medical Private Limited Rahul Luthra Director Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial Area Sonipat, Haryana 131028 India
Re: K210792
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: March 15, 2021 Received: March 15, 2021
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
August 25, 2021
1
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 (QS) 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 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) K210792
Device Name Auxein Nailing System (Sterile)
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. Gamma 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 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 -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 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 tumor 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)
3
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Image /page/4/Picture/0 description: The image shows the logo for Auxein. The logo consists of a stylized letter "A" inside a circle on the left, followed by the word "Auxein" in a bold, sans-serif font. The color of the logo is blue.
CORPORATE OFFICE:
7-A, Nirankari Colony,
Delhi - 110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028, Haryana, India
+91 99106 43658
+91 86077 70197 (FAX)
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 Pvt. Ltd. |
| Plot No. 168-169-170, Phase- IV, Kundli Industrial Area, HSIIDC, | |
| Sector-57, Sonepat-131028, Haryana. | |
| Contact Person Name: | Mr. Rahul Luthra |
| Title: | Director |
| Phone Number: | +91-9811720999 |
| Dated: | 10/03/2021 |
Throughout the submission Auxein Nailing System is covered under 510(k) Submission.
(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: Orthopaedic
Regulation Number: 21 CFR 888.3020, 21 CFR 888.3030
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Image /page/5/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white "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:
7-A, Nirankari Colony,
Delhi - 110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131020, Haryana, India
+91 99106 43658
+91 86077 70197 (FAX)
Variants/Types:
An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body.
The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).
(A.3) Identification of the Predicate Device:
Following are the predicate device 510(k) with which we are declaring substantial equivalence:
The following is the range of variants covered with their corresponding predicate devices.
| S.No. | Item Description | Predicate Device |
|---|---|---|
| 1. | Auxein Nailing System | K192003, Auxein Nailing System, (Primary Predicate) |
| K011857, Synthes USA PFNA-II Blade, (Reference Predicate) |
Note: K011857, Synthes USA PFNA-II Blade is a Reference predicate device for (Ajax Blade)
(A.4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labelling or promotional material for the device.
Device Description:
Nail Fixation
Auxein Brand of Expert Tibia Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & 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 8mm to 12mm; the length varies from 255mm. The screw implants are in corresponding diameter of 4.4mm & 4.8mm diameters with lengths varying as per the requirements and minimum length: 24mm to maximum length 90mm.
Auxein Brand of Expert Femoral Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, 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.The diameter of the nails varies from 9mm to 13mm; the length varies from 320mm to 440mm.The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 25mm to maximum length 130mm.
Auxein Brand of Ga-mma Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, Inner screw, locking bolts, Anti-rotation
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Image /page/6/Picture/0 description: The image shows the logo for Auxein. The logo consists of a stylized letter "A" inside of a circle on the left, followed by the word "Auxein" in blue text on the right. The font is sans-serif and the color is a medium blue.
Image /page/6/Picture/1 description: This image shows contact information for a company. The corporate office is located at 7-A, Nirankari Colony, Delhi-110009, India. The manufacturing unit is located at Plot No. 169-170, Phase-IV, Sector-57, Kundia Industrial Area, 15HOC, Sonepat-131028, Haryana, India. The phone number is +91 9910643658, and the fax number is +91 86077 70197. The website is www.auxein.com.
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 9mm to 13mm; the length varies from 180mm. The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.
Auxein Brand of Humeral Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, 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 6mm to 9mm; the length varies from 180mm to 320mm. The screw implants are in corresponding diameter of 3.5mm & 4.5mm diameters with lengths varying as per the requirements and minimum length: 20mm to maximum length 70mm.
Auxein Brand of AJAX Advance Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolts, Cephalic screw, Ajax Blade, and inner 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 9mm to 12mm: the length varies from 170mm to 420mm.The screw implants are in corresponding diameter of 4.9mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.
Auxein Brand of Elastic Nailing system consists of various shapes and sizes of sterile nails featuring end caps 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 1.5mm to 4.0mm; the total length of 440mm. The end caps are in corresponding diameter ranges from 1.5mm to 4.0mm diameters with length of 14mm & 25mm.
Auxein Brand of Retrograde Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & 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 9.5 to 12mm; the length varies from 180mm to 360mm. The screw implants are in corresponding diameter of 5.0mm diameters with lengths varying as per the requirements and minimum length: 32mm to maximum length 80mm.
Auxein Nailing System covered same products as of covered in K192003. In this addition Auxein Nailing System is offering sterile version of the nailing devices.
The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).
However, we are adding a new device i.e. Ajax Blade in this submission. The associated Instruments with the newly added device are tabulated below.
| S.No. | Item Description | Material |
|---|---|---|
| 1. | Inner Screwdriver, Hex 4.0mm | Stainless Steel as Per ASTM 899 |
| 2. | Inner Screw Holder, Hex 4.0mm | Stainless Steel as Per ASTM 899 |
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Image /page/7/Picture/0 description: The image contains the logo for Auxein. The logo consists of a blue circular emblem with a stylized "A" inside, followed by the word "Auxein" in a blue, sans-serif font. The overall design is clean and professional, suggesting a corporate or business identity.
Image /page/7/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, SIIDC, Sonepat-131020, Haryana, India. The phone number is +91 99106 43658, the fax number is +91 86077 70197, and the website is www.auxein.com.
| 3. | Container for AJAX Cephalic Screw
Instrument Set | Stainless Steel as Per ASTM 8 |
| ---- | ----------------------------------------------------- | ------------------------------- |
|---|
These implants will be supplied in Sterile State (Gamma Irradiation) Only.
(A.5) 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 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
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
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,
AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal fracture including Pertrochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.
The AUXEIN MEDICAL's Elastic Intramedullary Nail System
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-
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
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Image /page/8/Picture/0 description: The image shows the logo for Auxein. The logo consists of a stylized letter "A" inside of a circle, followed by the word "Auxein" in a sans-serif font. The logo is blue in color and the wordmark is to the right of the symbol.
Image /page/8/Picture/1 description: The image shows contact information for a company. The corporate office is located at 7-A, Nirankari Colony, Delhi - 110009, India. The manufacturing unit is located at Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, 15HDC, Sonepat-131020, Haryana, India. The phone number is +91 9910643638, and the fax number is +91 86077 70197. The website is www.auxein.com.
humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
AUXEIN Brand of Retrograde Nailing System
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 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 New Device
(Auxein Brand) | Remarks |
|-------|--------------------------|----------------------------------------------------------------------------------------------------------|------------|
| 1. | Indications for use | Identical Indications for use. | Equivalent |
| 2. | Material | Same material used in New Device and
Predicate device. | Equivalent |
| 3. | Performance Standards | Same performance standards used in
both New Device as well as predicate
device. | Equivalent |
| 4. | Sterilization (Gamma) | Earlier the predicate device was supplied
Non-sterile but the now device will be
supplied Sterile. | Equivalent |
| 5. | Dimensional Verification | Same dimensions are found in both New
Devices as well as Predicate device. | Equivalent |
Following is the summary of parameters in which the comparison has been verified:
(C.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 with first, as it is the basis of
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Image /page/9/Picture/0 description: The image shows the logo for Auxein. The logo consists of a stylized letter "A" inside of a circle on the left, followed by the word "Auxein" in blue text on the right. The font is sans-serif and the overall design is simple and modern.
Image /page/9/Picture/1 description: The image shows contact information for a company. The corporate office is located at 7-A, Nirankari Colony, Delhi-110009, India. The manufacturing unit is located at Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, Sonepat-131020, Haryana, India. The phone number is +91 99106 43638, and the fax number is +91 86077 70197. The website is www.auxein.com.
manufacturing metallic surgical implants.
We have complied with the following material standards.
-
ASTM F 136: Standard specification for wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
-
ASTM F 899-12: 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 are attached herewith.
B: Performance Standards:
The device's performance of Auxein Nailing System has been demonstrated against following applicable standards.
- ASTM F 543-17 ●
- ASTM F1264
- ASTM F384 ●
- Custom Fatigue Testing
(B.1). Discussion on the clinical evaluation referenced and relied upon:
Auxein Nailing System is of similar design and pattern as well as similar intended use.
Conclusion:
General, Safety and Performance conclusion:
| S.No. | Parameter of
Conclusion | Proposed Device | Predicate Device |
|-------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| 1. | Product Code | HSB, JDS | Same |
| 2. | Regulation Number | 21 CFR 888.3020, 21 CFR 888.3030 | Same |
| 3. | Regulatory Class | Class II | Same |
| 4. | Intended 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 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 | Same |
| | System | | |
| | 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 Ga-mma Nailing
System | | |
| | 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 fracture
in osteoporotic bone (including
prophylactic use) of the trochanteric and
diaphyseal fractures,
areas, impending
pathological fractures, long
subtrochanteric fractures, ipsilateral
femoral fractures, proximal or distal
non-unions, malunions, revision
procedures and tumor resections. | | |
| | AUXEIN Brand of AJAX Advance Nailing | | |
| | System,
AUXEIN Brand of AJAX Advance Nailing
System, end cap and screws is intended
to treat stable and unstable proximal
femoral fracture including
Pertrochanteric fractures,
Intertrochanteric fractures and High sub
trochanteric fractures and combination
of these fractures. | | |
| | The AUXEIN MEDICAL'S Elastic
Intramedullary Nail System | | |
| | 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 | |
| | | 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 | |
| | | 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." | |
| 5. | Sterilization
(Gamma) | Earlier the predicate device was supplied
Non-Sterile but the now scope device will
be supplied Sterile (Gamma Irradiation). | Same |
| 6. | Mechanical Test
Performance | • ASTM F543
• ASTM F384 | Same |
| | Screw-Cut Out Test ASTM F1264 | | |
| 7. | Material Standards ASTM F136 & ASTM F 899-12b. | Same | |
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Image /page/10/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue stylized letter "A" inside of a circle, 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:
7-A, Nirankari Colony,
Delhi - 110 009, India
MANUFACTURING UNIT
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028, Haryana, India
+91 99106 43638
+91 86077 70197 (FAX)
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Image /page/11/Picture/0 description: The image shows the logo for Auxein. The logo consists of a stylized letter "A" with a circular design around it, followed by the text "Auxein" in a sans-serif font. The color of the logo and text is blue.
510K Number: K210792
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Image /page/12/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a white triangle inside of it, and the word "Auxein" is written in blue letters to the right of the circle. The font is sans-serif and the letters are bolded.
Image /page/12/Picture/1 description: This 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, HSIIDC, Sonepat-131020, Haryana, India. The phone number is +91 9910643638, and the fax number is +91 86077 70197. The website is www.auxein.com.
From the data available we can justify that the Auxein Nailing System is as safe, and as effective and performs as same indications for use as that of already marketed predicate devices identified in A.3. of 510(k) summary. Hence our devices can be considered safe and effective for their intended use.
Non Clinical Testing
Gap assessment was performed between the previously cleared 510k and the new submission. Since this submission includes sterile version of products as new additions and no other technical changes are being included. No additional risk for mechanical testing and biocompatibility testing was identified.
We have performed the Mechanical Testing as per ASTM F384 and Screw Cut-Out test for the Ajax Blade.
The sterilization method was validated using the below standards:
- ASTM F1980-Standard Guide for Accelerated Aging of Sterile Barrier Systems for ● Medical Devices.
- ISO 11737-2:2019-Sterilization of health care products-Microbiological methods-Part . 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
Conclusion
Bases upon the non-clinical testing, the Auxein Nailing System has been demonstrated to be substantially equivalent to the predicate device and effective for its intended use.