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.

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 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 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.

Inner Screwdriver, Hex 4.0mm
Inner Screw Holder, Hex 4.0mm
Container for AJAX Cephalic Screw Instrument Set

These implants will be supplied in Sterile State (Gamma Irradiation) Only.

AI/ML Overview

The provided text is a 510(k) summary for the Auxein Nailing System, which is a medical device. This type of document is for premarket notification of a device to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It focuses on comparing the new device to existing ones based on design, materials, and intended use, and generally does not contain information about clinical studies with human participants, AI algorithms, or detailed performance metrics like sensitivity/specificity derived from such studies.

Therefore, many of the requested items, which are typical for studies involving AI algorithms or comparative effectiveness of diagnostic devices, are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for device performance beyond compliance with material and performance standards. The "performance" is demonstrated through adherence to these standards and comparison to a predicate device.

Acceptance Criteria (Standards Adherence)	Reported Device Performance (Compliance)
Material Standards:
ASTM F 136 (Wrought Titanium Alloy)	Complied with standard (material verified)
ASTM F 899-12 (Wrought Stainless Steels for surgical instruments)	Complied with standard (material verified)
Performance Standards:
ASTM F 543-17	Device's performance demonstrated against this standard
ASTM F1264 (Screw Cut-Out Test - specifically for Ajax Blade)	Device's performance demonstrated against this standard
ASTM F384	Device's performance demonstrated against this standard
Custom Fatigue Testing	Device's performance demonstrated against this testing
Sterilization Standards:
ASTM F1980 (Accelerated Aging of Sterile Barrier Systems)	Sterilization method validated using this standard
ISO 11737-2:2019 (Tests of sterility)	Sterilization method validated using this standard

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The testing described is non-clinical (material and mechanical), not involving human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. "Ground truth" in the context of clinical expert consensus is not relevant to the non-clinical testing performed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not an AI device. No MRMC study was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not an AI device. No standalone algorithm performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical testing is compliance with established engineering and material standards (e.g., ASTM F136 for material composition, ASTM F543 for mechanical properties).

8. The sample size for the training set

This information is not applicable and not provided. There is no AI training set for this device.

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no AI training set for this device.

Summary

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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

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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

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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)

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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)

www.auxein.com

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)

www.auxein.com

Variants/Types:

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 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 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 ScrewInstrument 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 andPredicate device.	Equivalent
3.	Performance Standards	Same performance standards used inboth New Device as well as predicatedevice.	Equivalent
4.	Sterilization (Gamma)	Earlier the predicate device was suppliedNon-sterile but the now device will besupplied Sterile.	Equivalent
5.	Dimensional Verification	Same dimensions are found in both NewDevices 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 ofConclusion	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 NailingSystemAUXEIN Brand of Expert Tibia NailingSystem- consists of variety of Bone nailsand bone screws. Expert Tibia NailSystem is intended to stabilize fracturesof the proximal and distal tibia and thetibial shaft; open and closed tibial shaftfractures; certain pre- and post-isthmicfractures; and tibial malunions and non-unions.AUXEIN Brand of Expert Femoral Nailing	Same
	System
	AUXEIN Brand of Expert Femoral NailingSystem -is intended to stabilize femoralshaft fractures, subtrochantericfractures, ipsilateral neck/shaft fractures,impending pathologic fractures,non-unions and malunions.
	AUXEIN Brand of Ga-mma NailingSystem
	AUXEIN Brand of Gamma Nailing System-The Gamma Nail with Anti -RotationScrew is intended to treat stable andunstable proximal fractures of the femurincluding pertrochanteric fractures,intertrochanteric fractures, highsubtrochanteric fractures andcombinations of these fractures,including non-union, malunion and tumorresections. The Long Nail system isadditionally indicated to treatpertrochanteric fractures associatedwith shaft fractures, pathologic fracturein osteoporotic bone (includingprophylactic use) of the trochanteric anddiaphyseal fractures,areas, impendingpathological fractures, longsubtrochanteric fractures, ipsilateralfemoral fractures, proximal or distalnon-unions, malunions, revisionprocedures and tumor resections.
	AUXEIN Brand of AJAX Advance Nailing
	System,AUXEIN Brand of AJAX Advance NailingSystem, end cap and screws is intendedto treat stable and unstable proximalfemoral fracture includingPertrochanteric fractures,Intertrochanteric fractures and High subtrochanteric fractures and combinationof these fractures.
	The AUXEIN MEDICAL'S ElasticIntramedullary Nail System
	The AUXEIN MEDICAL'S Elastic
		Intramedullary Nail System is indicatedfor fixation of diaphyseal fractures wherethe canal is narrow or flexibility of theimplant is important. This includes upperextremity fractures in all patients andlower extremity fractures in childrenabove the age of 6 years and any patientbelow 65 kg. This system is alsointended to treat metaphyseal andepiphyseal fractures, such as radial neckfractures.
		AUXEIN Brand of Humeral NailingSystem
		AUXEIN Brand of Humeral NailingSystem is indicated for fractures of theproximal humerus, including 2-partsurgical neck fractures, 3-part fractures,and 4-part fractures, proximal humeralfractures with diaphyseal extension,diaphyseal fractures of the humeralshaft, and impending pathologic humeralfractures.
		AUXEIN Brand of Retrograde NailingSystem
		AUXEIN Brand of Retrograde NailingSystem This nails are indicated forsimple long bone fractures; severelycomminuted, spiral, large oblique andsegmental fractures; nonunions andmalunions; polytrauma and multiplefractures; prophylactic nailing ofimpending pathologic fractures;reconstruction, following tumorresection and grafting; supracondylarfractures; bone lengthening andshortening. Interlocking intramedullarynails are indicated for fixation offractures that occur in and between theproximal and distal third of long bonesbeing treated."
5.	Sterilization(Gamma)	Earlier the predicate device was suppliedNon-Sterile but the now scope device willbe supplied Sterile (Gamma Irradiation).	Same
6.	Mechanical TestPerformance	• 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)

www.auxein.com

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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.

Regulation Number and Section

§ 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.