# K192003: Auxein Nailing System - Pathway: 510(k) (Traditional) - Applicant: Auxein Medical Private Limited - Decided: Jun 10, 2020 after 320 days - Product code: JDS (Nail, Fixation, Bone) - Device class: 2 - Regulation: 21 CFR 888.3030 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K970097 (1997). 41 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 44 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K962047: Titanium Cannulated Tibial Nail (TI CTN), Synthes (Usa) (1996) Summary page 7. - K000089: Synthes 4.0 and 5.0 MM Locking Screws, Synthes (Usa) (2000) Summary page 7. - K040762: Synthes (Usa) Tibial Nail System EX, Synthes (Usa) (2004) Summary page 7. - K040336: Synthes (Usa) Lateral Entry Femoral Nail System, Synthes (Usa) (2004) Summary page 7. - K100238: HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM, DePuy Orthopaedics, Inc. (2010) Summary page 7. - K012190: Aos Modular Femoral Nail, Advanced Orthopaedic Solutions, Inc. (2001) Summary page 7. - K970097: Proximal Femoral Nail (PFN) System, Synthes (Usa) (1997) Summary page 9. - K131548: Synthes Trochanteric Fixation Nail - Advanced System, Synthes (USA) Products, LLC (2014) Summary page 9. - K032687: Ace Nancy Nail, DePuy Orthopaedics, Inc. (2003) Summary page 9. - K120807: Synthes Multiloc Humeral Nailing System, Synthes USA Products, LLC (2012) Summary page 9. - K033071: Synthes (Usa) Cannulated Titanium Humeral Nail System, Synthes (Usa) (2003) Summary page 9. - K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails, Smith & Nephew, Inc. (2005) Summary page 10. ## Most influential descendants - K230071: Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System (2024), 0 descendants of its own - K210792: Auxein Nailing System (2021), 0 descendants of its own ## Indications for use 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 distal tibia 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 femoral 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, Intertrochanteric 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 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 . 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 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. Source page: https://510kreport.com/device/K192003 Methodology: https://510kreport.com/methodology