# K100238: HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM - Pathway: 510(k) (Traditional) - Applicant: DePuy Orthopaedics, Inc. - Decided: May 11, 2010 after 104 days - Product code: HSB (Rod, Fixation, Intramedullary And Accessories) - Device class: 2 - Regulation: 21 CFR 888.3020 - Recalls of this device: 250 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K970097 (1997). 11 ancestors in all. 7 later devices descend from it; 3 cite it directly. 0 of 19 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K042325: Trochanteric Nail System, DePuy Orthopaedics, Inc. (2004) Summary page 1. - K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 1. ## Most influential descendants - K192003: Auxein Nailing System (2020), 2 descendants of its own - K183162: Affixus Hip Fracture Nail (2018), 2 descendants of its own - 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 - K233910: Vertex Hip Fracture Nailing System (2024), 0 descendants of its own - K221489: Artemis Proximal Femoral Nail System (2022), 0 descendants of its own ## Recalls of this device - Oct 2, 2018 · Class II · Z-0449-2019: The set screw is not able to advance or reverse from the original position in the nail. - Oct 2, 2018 · Class II · Z-0452-2019: The set screw is not able to advance or reverse from the original position in the nail. - Oct 2, 2018 · Class II · Z-0447-2019: The set screw is not able to advance or reverse from the original position in the nail. - Oct 2, 2018 · Class II · Z-0454-2019: The set screw is not able to advance or reverse from the original position in the nail. - Oct 2, 2018 · Class II · Z-0453-2019: The set screw is not able to advance or reverse from the original position in the nail. - Oct 2, 2018 · Class II · Z-0451-2019: The set screw is not able to advance or reverse from the original position in the nail. - Oct 2, 2018 · Class II · Z-0448-2019: The set screw is not able to advance or reverse from the original position in the nail. - Oct 2, 2018 · Class II · Z-0450-2019: The set screw is not able to advance or reverse from the original position in the nail. - Aug 8, 2018 · Class II · Z-0164-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0140-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0151-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0150-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0134-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0139-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0146-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0152-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0157-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0166-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0168-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0124-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0129-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0155-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0154-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0158-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0161-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0163-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0149-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0133-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0159-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0137-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0138-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0136-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0142-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0126-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0156-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0141-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0165-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0148-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0167-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0153-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0169-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0128-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0130-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0125-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0123-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0162-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0131-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0143-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0122-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. - Aug 8, 2018 · Class II · Z-0144-2019: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. ## Indications for use The Hip Fracture Nail System 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. Source page: https://510kreport.com/device/K100238 Methodology: https://510kreport.com/methodology