Auxein Nailing System

K192003 · Auxein Medical Private Limited · JDS · Jun 10, 2020 · Orthopedic

Device Facts

Record IDK192003
Device NameAuxein Nailing System
ApplicantAuxein Medical Private Limited
Product CodeJDS · Orthopedic
Decision DateJun 10, 2020
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3030
Device ClassClass 2
AttributesTherapeutic, 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 tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions. AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections. AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures. The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures . AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures. AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following turnor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.

Device Story

Auxein Nailing System comprises titanium intramedullary nails, screws, and end caps 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 provided non-sterile; require autoclaving by user prior to surgery. Output is mechanical stabilization of bone segments; enables patient mobilization and fracture union. Benefits include restoration of skeletal alignment and support for bone healing.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing (mechanical performance per ASTM F1264, F384, F543) and material compliance (ASTM F136, F899-12b). Clinical evaluation relied on clinical equivalence documentation per MEDDEV 2.7/1.

Technological Characteristics

Materials: Titanium-6Al-4V ELI (ASTM F136) and wrought stainless steel (ASTM F899-12b). Mechanical fixation via intramedullary nails, locking bolts, and screws. Dimensions vary by module (Nails: 1.5mm-13mm diameter; 170mm-440mm length). Sterilization: Non-sterile, requires autoclaving. No software or electronic components.

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. Contraindications not specified.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 10, 2020 Auxein Medical Private Limited Rahul Luthra Director, Regulatory Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli Industrial area Sonepat, IN 131028 Haryana Re: K192003 Trade/Device Name: Auxein Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, JDS Dated: April 23, 2020 Received: April 23, 2020 Dear Rahul Luthra: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K192003 Device Name Auxein Nailing system #### Indications for Use (Describe) Device Name: Auxein Nailing System are categorized to the following system: 1. Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Ga-mma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System INDICATION FOR USE: 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 the 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, 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. 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 turnor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) {3}------------------------------------------------ #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text 'K192003' in a simple, sans-serif font. The text is presented in a single line, with each character clearly legible. The alphanumeric sequence appears to be a code or identifier, possibly a product or serial number. Image /page/4/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. The logo is simple and modern, and the blue color gives it a sense of trust and reliability. CORPORATE OFFICE: 7-A, Nirankari Colony, Delhi-110 009, India MANUFACTURING UNIT Plot No. 169-170, Phase-IV, +91 99106 43638 +91 86077 70197 (FAX) .auxein.com # Section 5.0 - 510K Summary # Premarket Notification 510(k) Summary as required by Section 807.92 General Company Information as required by 807:92 (a) (A.1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared | Submitter's Name: | Auxein Medical Private Limited. | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Auxein Medical Private Limited,<br>Plot Number 168-169-170, Phase-IV,<br>Kundli Industrial Area, HSIIDC, Sector-57,<br>Sonepat, Haryana – 131028, India | | Contact Person Name: | Mr. Rahul Luthra | | Title: | Director | | Phone Number: | +91-9811720999 | | Dated: | 07.03.2020 | Throughout the submission Auxein Brand of Nails are covered under this 510(k) submission. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a sans-serif font. The logo is simple and modern. 7-A, Nirankari Colony, Delhi - 110 009, India **MANUFACTURING UNIT** Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, IIDC, Sonepat-131028, Haryana, India +91 99106 43638 6077 70197 (FAX) .auxein.com A.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known # Proprietary Name: Auxein Nailing System ### Common or Usual Name: Rod, Fixation, Intramedullary and Accessories Nail, Fixation, Bone ### Classification Name: Intramedullary Fixation Rod. Single/multiple component metallic bone fixation appliances and accessories ### Product Code: HSB, JDS Device Class: II Review Panel: Orthopedic Regulation Number: 21 CFR 888.3020, 21 CFR 888.3030 ### Variants/Types: Auxein Nailing System is divided in following categories. | S. No. | Name | |--------|-------------------------------| | 01 | Expert Tibia Nailing System | | 02 | Expert Femoral Nailing System | | 03 | Ga-mma Nailing System | | 04 | AJAX Advance nailing system | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. The "A" in the circle is also stylized, with a curved line connecting the two sides of the letter. CORPORATE OFFICE: 7-A, Nirankari Colony, Delhi - 110 009, India MANUFACTURING UNIT Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, Sonepat-131028, Haryana, India +91 99106 43638 +91 86077 70197 (FAX) .auxein.com | 05 | Elastic Nailing System | |----|---------------------------| | 06 | Humeral Nailing System | | 07 | Retrograde Nailing System | The aforementioned Nails are used with End cap, locking bolt, Cannulated Anti-Rotation screw, proximal screw, Inner screw, compression screw and Cephalic Screw. #### A.3) Identification of the Predicate Device: Following are the predicate device 510(k) with which we are declaring substantial equivalence: Following is the range of variants covered with their corresponding predicate devices. | S.No. | Item Description | Predicate Device | |-------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Expert Tibia Nail | K962047, SYNTHES (USA) TITANIUM CANNULATED TIBIAL NAIL (TI<br>CTN) | | 2. | End cap for Expert Tibia Nail | | | 3. | Ø 4.4 mm locking bolt | K000089,SYNTHES (USA), Locking screws | | 4. | Ø 4.8 mm Locking bolt, self-tapping | K040762, SYNTHES (USA) TIBIAL NAIL SYSTEM EX | | 5. | Expert Femoral Nail, Left | | | 6. | Expert Femoral Nail, Right | K040336, SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM | | 7. | Ø 6.4 mm Cannulated Anti-Rotation Screw,<br>Self-Tapping for Expert Femoral Nail | | | 8. | End Cap for Expert Femoral Nail | | | 9. | 130° Anti-Rotation Ga-mma Nail, Long, Left | K100238 DEPUY ORTHOPAEDICS, INC | | 9. | 130° Anti-Rotation Ga-mma Nail, Long,<br>Right | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM,<br>K012190, ADVANCED ORHTOPAEDIC SOLUTION, AOS Modular<br>Femoral Nail | | 10. | 130° Anti-Rotation Ga-mma Nail, Short | | | 11 | Inner Screw For Anti-Rotation Ga-mma Nail - Long | | | 12 | Inner Screw For Anti-Rotation Ga-mma Nail - Short | K100238 DEPUY ORTHOPAEDICS, INC<br>HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, | | 13 | Ø6.4mm Cannulated Anti-Rotation Screw | | | 14 | 130° Ga-mma Nail Type-II, Short | | | 15 | 130° Ga-mma Nail, Type-II, Long, Left | | | 16 | 130° Ga-mma Nail, Type-II, Long, Right | | | 17 | End Cap For Ga-mma Nail Type-II | | | 18 | End Cap For Ø10.5mm Cephalic Screw For Ga-mma Nail | | | 19 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mm Nail | K962047 SYNTHES (USA) TITANIUM CANNULATED TIBIAL NAIL (TI CTN) | | 20 | Ø10.5mm Cephalic Screw For Ga-mma Nail | | | 21 | Inner Screw For Ga-mma Nail Type-II | | | 22 | 130° AJAX Advance Nail, Short, | | | 23 | 130° AJAX Advance Nail, Long, Left | K100238 DEPUY ORTHOPAEDICS, INC<br>HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, | | 24 | 130° AJAX Advance Nail, Long, Right | | | 25 | 125° AJAX Advance Nail, Short, | | | 26 | 125° AJAX Advance Nail, Long, Left | | | 27 | 125° AJAX Advance Nail, Long, Right, | | | | | | | 28 | AJAX Ø 4.9mm Locking Bolt, Self-Tapping | | | 29 | Ajax Cephalic Screws | K970097, SYNTHES(USA) PROXIMAL FEMORAL NAIL (PFN) SYSTEM<br>K131548,SYNTHES (USA), Synthes Trochanteric Fixation Nail -<br>Advanced System, used as predicate for Ajax Cephalic screws | | 30 | End Cap (For Cephalic Screws) | | | 31 | Inner Screws for Ajax Cephalic Screws | | | 32 | Ajax Nail end cap( for cephalic Screws) | | | 33 | Titanium Elastic Nail | K032687 ACE NANCY NAIL DEPUY ORTHOPAEDICS, INC. 700<br>ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 | | 34 | End cap for Titanium Elastic Nail, Size- 1 | | | 35 | End cap for Titanium Elastic Nail, Size- 2 | | | 36 | Reconstruction Nail,Cannulated | | | 37 | Ø 3.5mm Locking Bolt | | | 38 | End Cap for Reconstruction cannulated<br>intramedullary Humeral Nail | K120807, SYNTHES MULTILOC HUMERAL NAILING SYSTEM | | 39 | Reconstruction cannulated intramedullary<br>Humeral Nail | | | 40 | 4.5 mm Locking Bolt for Intramedullary<br>Cannulated Humeral Nail | | | 41 | 4.5 mm proximal Screw | | | 42 | Intramedullary Cannulated Humeral Nail | | | 43 | End Cap for Intramedullary Cannulated<br>Humeral Nail | K033071,SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL<br>SYSTEM | | 44 | Compression Screw for Intramedullary<br>Cannulated Humeral Nail | | | 45 | Retrograde Femoral Nail | K051557, SMITH & NEPHEW, INC TRIGEN RETROGRADE FEMORAL,<br>SUPRACONDYLAR AND TIBIAL NAILS | | 46 | End Cap For Retrograde Femoral Nail | | | 47 | 5.0 MM Locking Bolt Retrograde Nail | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it. To the right of the circle is the word "Auxein" in blue, with the same font as the "A" in the circle. CORPORATE OFFICE: MANUFACTURING UNIT Sector-Sector-Sector-Section J +91 99106 43638 +91 86077 70197 (FAX) {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability. CORPORATE OFFICE: MANUFACTURING UNIT Sector-Sector-Sector-Section +91 99106 43638 +91 86077 70197 (FAX) 8 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a blue letter A inside of it. To the right of the circle is the word "Auxein" in blue. K192003 CORPORATE OFFICE: 7-A, Nirankari Colony, Delhi-110 009, India MANUFACTURING UNIT Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, Sonepat-131028, Haryana, India +91 99106 43638 +91 86077 70197 (FAX) # A.4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device ## Device Description: ### Nail Fixation Auxein Brand of Expert Tibia Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 8 mm to 12 mm; the length varies from 255 mm to 375 mm. The screw implants are in corresponding diameter of 4.4 mm & 4.8 mm diameters with lengths varying as per the requirements and minimum length: 18 mm to maximum length 90 mm. Auxein Brand of Expert Femoral Nail system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking screw & Anti-rotation screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized letter "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a serif font. CORPORATE OFFICE: 7-A, Nirankari Colony, Delhi - 110 009, India MANUFACTURING UNIT Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, SIIDC, Sonepat-131028, Haryana, India +010 The diameter of the nails varies from 9 mm to 13 mm; the length varies from 320 mm to 440 mm. The screw implants are in corresponding diameter of 4.8 mm, 6.4 mm diameters with lengths varying as per the requirements and minimum length: 25 mm to maximum length 130 mm. Auxein Brand of Ga-mma Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, Inner screw, locking bolts, Antirotation screw & Cephalic screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9 mm to 13 mm; the length varies from 180 mm to 440 mm. The screw implants are in corresponding diameter of 4.8 mm, 6.4mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm. Auxein Brand of Humeral Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking bolt, compression screw, and proximal screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 7mm to 9 mm; the length varies from 180 mm to 320 mm. The screw implants are in corresponding diameter of 3.5 mm & 4.5 mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 70mm. Auxein Brand of AJAX Advance Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap, locking bolts, Cephalic screw, inner screw of different sizes. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the text "K192003" in a simple, sans-serif font. The text is black against a white background. The letters and numbers are evenly spaced and clearly legible. Image /page/11/Picture/1 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it. To the right of the circle is the word "Auxein" in blue, sans-serif font. 7-A, Nirankari Colony, Delhi-110 009, India **MANUFACTURING UNIT** Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, SIIDC, Sonepat-131028, Haryana, India +91 99106 43638 +91 86077 70197 (FAX) The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9 mm to 12 mm; the length varies from 170 mmto 420 mm. The screw implants are in corresponding diameter of 4.9 mm & 10.5 mm diameters with lengths varying as per the requirements and minimum length: 26 mm to maximum length 120 mm. Auxein Brand of Elastic Nailing system consists of various shape and sizes of nails featuring end cap of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 1.5 mm to 4.0 mm; the total length of 440 mm. The end caps are in corresponding diameter ranges from 1.5 mm to 4.0 mm diameters with length of 14 mm & 25 mm. Auxein Brand of Retrograde Nailing system consists of various shape and sizes of nails featuring proximal & distal holes, End cap & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 10 mm to 12 mm; the length varies from 180 mm to 360 mm. The screw implants are in corresponding diameter of 5.0 mm diameters with lengths varying as per the requirements and minimum length: 32 mm to maximum length 80 mm. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized letter A inside of it. To the right of the circle is the word "Auxein" in blue, with a font that matches the letter A in the circle. CORPORATE OFFICE: 7-A, Nirankari Colony, Delhi - 110 009, India MANUFACTURING UNIT Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, SIIDC, Sonepat-131028, Haryana, India +91 99106 43638 +91 86077 70197 (FAX) These implants are sold non-sterile, the products have to be sterilized prior to use. # A5). A statement of the intended use of the device ## Indications for Use: - . AUXEIN Brand of Expert Tibia Nailing System- AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and distal tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions. - AUXEIN Brand of Expert Femoral Nailing System Expert Femoral Nail is ● intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. - AUXEIN Brand of Ga-mma Nailing System The Gamma Nail with Anti-Rotation ● Screw is intended to treat stable and unstable proximal fractures of the femur including per trochanteric fractures, intertrochanteric fractures, high sub trochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat per trochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long sub trochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections. - AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended ● to treat stable and unstable proximal femoral fracture including Per trochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fracture. - The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is important. This includes upper extremity fractures in all patients and lower extremity fractures in children {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. The font is sans-serif and the overall design is simple and modern. **CORPORATE OFFICE:** 7-A, Nirankari Colony, Delhi - 110 009, India **MANUFACTURING UNIT** Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, SIIDC, Sonepat-131028, Haryana, India +91 99106 43638 +91 86077 70197 (FAX) .auxein.com above the age of 6 years and any patient below 65 kg. This system is also intended to trea metaphyseal and epiphyseal fractures, such as radial neck fractures. - AUXEIN Brand of Humeral Nailing System This Nail indicated for fractures of . the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures. - AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple ● long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures: reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated. ## A.6). Summary of Technological Characteristics as compared to the predicate devices: #### Substantial equivalence including comparison with predicate devices A comparison between the Auxein Brand of Nails, screws, and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue, sans-serif font. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability. .auxein.com Following is the summary of parameters in which the comparison has been verified: | S. No. | Characteristics | Predicate Device Versus New<br>Device (Auxein Brand) | Remarks | |--------|-----------------------------|----------------------------------------------------------------------------------------|------------| | 01 | Indications for use | Similar intended use in New Device<br>and Predicate device | Equivalent | | 02 | Material | Same material used in New Device<br>and Predicate device | Equivalent | | 03 | Performance<br>Standards | Same performance standards used in<br>both New Device as well as predicate<br>device | Equivalent | | 04 | Sterilization | Same method of sterilization used in<br>both New Device as well as<br>Predicate device | Equivalent | | 05 | Dimensional<br>Verification | Similar dimensions found in both<br>New Device as well as Predicate<br>device | Equivalent | ### B.1). Discussion on the non-clinical testing performed Following are the applicable product standards considered for non-clinical standards - A: Material Standards - B: Performance Standards #### A: Material Standards: The material standards are the essential part to be complied to first, as it is the basis of manufacturing metallic surgical implants. We have complied with following material standards {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. The font is sans-serif and the overall design is simple and modern. K192003 CORPORATE OFFICE: 7-A, Nirankari Colony, Delhi-110 009, India MANUFACTURING UNIT Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, SIIDC, Sonepat-131028, Haryana, India +91 99106 43638 +91 86077 70197 (FAX) - 1. ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications. - 2 ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments. We have verified the purchased material compliance to these standards and copies of the relevant test results is attached herewith #### B: Performance Standards: The device performance of Auxein Brand of Nails, screws, has been demonstrated against following applicable standards - ASTM F 1264 . - . ASTM F 384 - ASTM F 543 . - B.2). Discussion on the clinical evaluation referenced and relied upon: . Auxein Brand of devices is of similar design and pattern as well as similar intended use. Under such situation we have also considered the meddev guidance document MEDDEV2.71 REV.04: 2016 and as per that clinical evaluation / clinical equivalence has been documented in section 11. #### CONCLUSION: #### General, Safety and Performance conclusion: | S. No. | Parameter of<br>Conclusion | Proposed Device | Predicate<br>Device | |--------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | 01 | Product Code | HSB<br>JDS | Same | | 02 | Regulation<br>Number | 21 CFR 888.3020<br>21 CFR 888.3030 | Same | | 03 | Regulatory<br>Class | Class II | Same | | 04 | Intended Use | AUXEIN Brand of Expert Tibia Nailing<br>System- consists of variety of Bone nails<br>and bone screws. Expert Tibia Nail System<br>is intended to stabilize fractures of the<br>proximal and distal tibia and the tibial shaft;<br>open and closed tibial shaft fractures;<br>certain pre and post-isthmic fractures; and<br>tibial malunions and non- unions. Auxein Brand of Expert Femoral Nailing<br>System - Expert Femoral Nail is intended to<br>stabilize femoral shaft fractures, sub<br>trochanteric fractures, ipsilateral neck/shaft<br>fractures, impending pathologic fractures,<br>non-unions and malunions. Auxein Brand Gamma Nailing system - The<br>Gamma Nail with Anti-Rotation Screw is<br>intended to treat stable and unstable proximal<br>fractures of the femur including per trochanteric<br>fractures, intertrochanteric fractures, high sub<br>trochanteric fractures and combinations of these<br>fractures, including non-union, malunion and<br>tumor resections. The Long Nail system is<br>additionally indicated to treat per trochanteric<br>fractures associated with shaft fractures,<br>pathologic fractures in osteoporotic bone<br>(including prophylactic use) of the trochanteric<br>and diaphyseal areas, impending pathological<br>fractures, long sub trochanteric fractures,<br>ipsilateral femoral fractures, proximal or distal<br>non-unions, malunions, revision procedures and<br>tumor resections. | Similar<br>Intended<br>Use | {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the word "Auxein" in blue font. To the left of the word is a blue circle with a stylized letter "A" inside. The letter "A" is also in blue and has a similar font to the word "Auxein". The background of the image is white. CORPORATE OFFFICE: O 7-A, Nirankari Colony, Delhi - 110 009, India MANUFACTURING UNIT Sector-Sector-Sector-Section +91 99106 43638 +91 86077 70197 (FAX) J {17}------------------------------------------------ Image /page/17/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. The logo is simple and modern, and the blue color gives it a sense of trust and reliability. CORPORATE OFFICE: MANUFACTURING UNIT +91 99106 43638 +91 86077 70197 (FAX) www.auxein.com 3 2 | <b>Auxein Brand of AJAX Advance Nailing System</b> , end cap and screws is intended to treat stable and unstable proximal femoral fracture including Per trochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fracture. | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <b>The AUXEIN MEDICAL'S Elastic Intramedullary Nail System</b> 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. | | <b>AUXEIN Brand of Humeral Nailing System</b><br>- This Nail indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures. | {18}------------------------------------------------ Image /page/18/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. The font is sans-serif and the logo is simple and modern. CORPORATE OFFICE: MANUFACTURING UNIT Sector-Sector-Sector-Section +91 99106 43638 +91 86077 70197 (FAX) 8 | <ul><li>AUXEIN Brand of Retrograde Nailing System - This nail are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.</li></ul> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {19}------------------------------------------------ Image /page/19/Picture/0 description: The image shows the logo for Auxein. The logo consists of a blue circle with a stylized letter "A" inside of it. To the right of the circle is the word "Auxein" in blue, with a font that is similar to Times New Roman. Image /page/19/Picture/1 description: The image shows contact information for a company. The corporate office is located at 7-A, Nirankari Colony, Delhi - 110 009, India. The manufacturing unit is located at Plot No. 169-170, Phase-IV, Sector-57, Kundli Industrial Area, Sonepat-131028, Haryana, India. The phone number is +91 99106 43638 and the fax number is +91 86077 70197. www.auxein.com | 05 | Sterilization | Provided Non-Sterile and to be sterilized using<br>Autoclaving Method to achieve SAL of 10-6 | Same | |----|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|------| | 06 | Mechanical<br>Test<br>Performance | For Nails & Screws:<br>As per ASTM F 1264,ASTM F 384,ASTM F 543<br>Standard Specification and Test Methods for<br>Intramedullary Fixation Devices | Same | | 07 | Material<br>Standards | ASTM F 136 & ASTM F 899-12b | Same | The data described above completely supports the substantial equivalence of the Auxein brand of nailing system to the predicate devices listed.
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