# K083726: Pedinail Intramedullary Nailing System - Pathway: 510(k) (Traditional) - Applicant: OrthoPediatrics Corp. - Decided: Mar 11, 2009 after 86 days - Product code: HSB (Rod, Fixation, Intramedullary And Accessories) - Device class: 2 - Regulation: 21 CFR 888.3020 - Recalls of this device: 27 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K982953 (1998). 10 ancestors in all. 6 later devices descend from it; 2 cite it directly. 0 of 17 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K040929: Trigen Adolescent Tan, Smith & Nephew, Inc. (2004) Summary page 1. - K070843: Synthes Adolescent Lateral Entry Femoral Nail System, Synthes (Usa) (2007) Summary page 1. - K983942: Intramedullary Nail System, Locking Screw, Nail Cap, Smith & Nephew, Inc. (1998) Summary page 1. - K993956: Titanium Pediatric Femoral Nail, Biomet, Inc. (1999) Summary page 1. - K072161: Biomet Femoral Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 1. - K040336: Synthes (Usa) Lateral Entry Femoral Nail System, Synthes (Usa) (2004) Summary page 1. ## Most influential descendants - K172583: OrthoPediatrics PediNail Intramedullary Platform (2018), 4 descendants of its own - K220679: Pediatric Nailing Platform Femur (2022), 2 descendants of its own - K250623: Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (2025), 1 descendant of its own - K261345: Pediatric Nailing Platform Femur (2026), 0 descendants of its own - K190321: Pediatric Nailing PlatformFemur (2019), 0 descendants of its own ## Recalls of this device - Nov 18, 2016 · Class III · Z-0879-2017: Labeled as a 48mm Cortical Screw but measuring at 50mm - Jul 21, 2009 · Not classified · Z-0339-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0342-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0345-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0346-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0348-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0350-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0351-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0353-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-034-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0347-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0352-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0357-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0361-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0362-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0363-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0341-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0344-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0349-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0354-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0355-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0356-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0358-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0359-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0343-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0360-2010: The potential exists for the nails to fracture during insertion of the nail. - Jul 21, 2009 · Not classified · Z-0364-2010: The potential exists for the nails to fracture during insertion of the nail. ## Indications for use The OrthoPediatrics PediNailTM system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) .for correction of deformity. Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNailTM is for single use only. Source page: https://510kreport.com/device/K083726 Methodology: https://510kreport.com/methodology