Auxein Nailing System

K210792 · Auxein Medical Private Limited · HWC · Aug 25, 2021 · Orthopedic

Device Facts

• Record ID: K210792
• Device Name: Auxein Nailing System
• Applicant: Auxein Medical Private Limited
• Product Code: HWC · Orthopedic
• Decision Date: Aug 25, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 -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 fracture including Pertrochanteric fractures, Intertrochanteric 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 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 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 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.

Device Story

Auxein Nailing System comprises titanium alloy (Ti-6Al-4V ELI) intramedullary nails, locking bolts, screws, and end caps; used for orthopedic fracture fixation. System includes Expert Tibia, Expert Femoral, Gamma, AJAX Advance, Elastic, Humeral, and Retrograde nailing modules. Devices are implanted by surgeons in clinical settings to stabilize bone fractures; facilitate healing via rigid or flexible internal fixation. Implants are supplied sterile via gamma irradiation. System includes associated stainless steel instruments (screwdrivers, holders, containers). Output is mechanical stabilization of bone segments; aids in patient recovery and bone union.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via mechanical testing including fatigue testing, screw cut-out tests (ASTM F1264), and compliance with ASTM F543 and F384. Sterilization validated per ISO 11737-2 and accelerated aging per ASTM F1980.

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V ELI (ASTM F136) for implants; Stainless Steel (ASTM F899) for instruments. Principle: Intramedullary fixation rod. Form factor: Various nail diameters (1.5mm-13mm) and lengths. Sterilization: Gamma irradiation. Connectivity: None (mechanical device).

Indications for Use

Indicated for stabilization of long bone fractures (tibia, femur, humerus) including shaft, proximal, distal, comminuted, spiral, oblique, segmental, and pathologic fractures; non-unions; malunions; polytrauma; tumor resections; and bone lengthening/shortening. Elastic nails indicated for pediatric patients (>6 years, <65 kg) and narrow canals. Specific contraindications not listed.

Regulatory Classification

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.

Predicate Devices

• Auxein Nailing System (K192003)

Reference Devices

• Synthes USA PFNA-II Blade (K011857)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

1. 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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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

[phone]
[phone] (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: | [phone] |
| 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

[phone]
[phone] (FAX)

www.auxein.com

### 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)<br>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 [phone], and the fax number is [phone]. 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 [phone], the fax number is [phone], and the website is www.auxein.com.

| 3. | Container for AJAX Cephalic Screw<br>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 [phone], and the fax number is [phone]. 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<br>(Auxein Brand) | Remarks |
|-------|--------------------------|----------------------------------------------------------------------------------------------------------|------------|
| 1. | Indications for use | Identical Indications for use. | Equivalent |
| 2. | Material | Same material used in New Device and<br>Predicate device. | Equivalent |
| 3. | Performance Standards | Same performance standards used in<br>both New Device as well as predicate<br>device. | Equivalent |
| 4. | Sterilization (Gamma) | Earlier the predicate device was supplied<br>Non-sterile but the now device will be<br>supplied Sterile. | Equivalent |
| 5. | Dimensional Verification | Same dimensions are found in both New<br>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 [phone], and the fax number is [phone]. The website is www.auxein.com.

manufacturing metallic surgical implants.

We have complied with the following material standards.

1. ASTM F 136: Standard specification for wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.

2. 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<br>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<br>System<br>AUXEIN Brand of Expert Tibia Nailing<br>System- consists of variety of Bone nails<br>and bone screws. Expert Tibia Nail<br>System is intended to stabilize fractures<br>of the proximal and distal tibia and the<br>tibial shaft; open and closed tibial shaft<br>fractures; certain pre- and post-isthmic<br>fractures; and tibial malunions and non-<br>unions.<br>AUXEIN Brand of Expert Femoral Nailing | Same |
| | System | | |
| | AUXEIN Brand of Expert Femoral Nailing<br>System -is intended to stabilize femoral<br>shaft fractures, subtrochanteric<br>fractures, ipsilateral neck/shaft fractures,<br>impending pathologic fractures,<br>non-unions and malunions. | | |
| | AUXEIN Brand of Ga-mma Nailing<br>System | | |
| | AUXEIN Brand of Gamma Nailing System<br>-The Gamma Nail with Anti -Rotation<br>Screw is intended to treat stable and<br>unstable proximal fractures of the femur<br>including pertrochanteric fractures,<br>intertrochanteric fractures, high<br>subtrochanteric fractures and<br>combinations of these fractures,<br>including non-union, malunion and tumor<br>resections. The Long Nail system is<br>additionally indicated to treat<br>pertrochanteric fractures associated<br>with shaft fractures, pathologic fracture<br>in osteoporotic bone (including<br>prophylactic use) of the trochanteric and<br>diaphyseal fractures,<br>areas, impending<br>pathological fractures, long<br>subtrochanteric fractures, ipsilateral<br>femoral fractures, proximal or distal<br>non-unions, malunions, revision<br>procedures and tumor resections. | | |
| | AUXEIN Brand of AJAX Advance Nailing | | |
| | System,<br>AUXEIN Brand of AJAX Advance Nailing<br>System, end cap and screws is intended<br>to treat stable and unstable proximal<br>femoral fracture including<br>Pertrochanteric fractures,<br>Intertrochanteric fractures and High sub<br>trochanteric fractures and combination<br>of these fractures. | | |
| | The AUXEIN MEDICAL'S Elastic<br>Intramedullary Nail System | | |
| | The AUXEIN MEDICAL'S Elastic | | |
| | | Intramedullary Nail System is indicated<br>for fixation of diaphyseal fractures where<br>the canal is narrow or flexibility of the<br>implant is important. This includes upper<br>extremity fractures in all patients and<br>lower extremity fractures in children<br>above the age of 6 years and any patient<br>below 65 kg. This system is also<br>intended to treat metaphyseal and<br>epiphyseal fractures, such as radial neck<br>fractures. | |
| | | AUXEIN Brand of Humeral Nailing<br>System | |
| | | AUXEIN Brand of Humeral Nailing<br>System is indicated for fractures of the<br>proximal humerus, including 2-part<br>surgical neck fractures, 3-part fractures,<br>and 4-part fractures, proximal humeral<br>fractures with diaphyseal extension,<br>diaphyseal fractures of the humeral<br>shaft, and impending pathologic humeral<br>fractures. | |
| | | AUXEIN Brand of Retrograde Nailing<br>System | |
| | | AUXEIN Brand of Retrograde Nailing<br>System This nails are indicated for<br>simple long bone fractures; severely<br>comminuted, spiral, large oblique and<br>segmental fractures; nonunions and<br>malunions; polytrauma and multiple<br>fractures; prophylactic nailing of<br>impending pathologic fractures;<br>reconstruction, following tumor<br>resection and grafting; supracondylar<br>fractures; bone lengthening and<br>shortening. Interlocking intramedullary<br>nails are indicated for fixation of<br>fractures that occur in and between the<br>proximal and distal third of long bones<br>being treated." | |
| 5. | Sterilization<br>(Gamma) | Earlier the predicate device was supplied<br>Non-Sterile but the now scope device will<br>be supplied Sterile (Gamma Irradiation). | Same |
| 6. | Mechanical Test<br>Performance | • ASTM F543<br>• 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

[phone]
[phone] (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 [phone], and the fax number is [phone]. 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.