# K013563: Long Trochanteric Nail System - Pathway: 510(k) (Traditional) - Applicant: DePuy Orthopaedics, Inc. - Decided: Dec 27, 2001 after 62 days - Product code: HSB (Rod, Fixation, Intramedullary And Accessories) - Device class: 2 - Regulation: 21 CFR 888.3020 - Recalls of this device: 54 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K970097 (1997). 5 ancestors in all. 70 later devices descend from it; 3 cite it directly. 0 of 76 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K010780: Trochanteric Nail, DePuy Orthopaedics, Inc. (2001) Summary page 1. - K871539: Zindrick IM Rod, Buckman Co., Inc. (1987) Summary page 1. - K973240: Synthes Proximal Femoral Nail (PFN) System Modification, Synthes (Usa) (1997) Summary page 1. - K981529: Titanium Intramedullary Nail, Titanium Locking Screw, Smith & Nephew, Inc. (1998) Summary page 1. ## Most influential descendants - K033329: Depuy Ace Universal and Troch Entry Femoral Nail Systems (2003), 53 descendants of its own - K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (2009), 39 descendants of its own - K101622: Zimmer Natural Nail System Retrograde Femoral Nails (2010), 29 descendants of its own - K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own - K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 16 descendants of its own ## Recalls of this device - Dec 20, 2017 · Class II · Z-1228-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1229-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1227-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1235-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1231-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1232-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1234-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1226-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1233-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1230-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 20, 2017 · Class II · Z-1225-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta - Dec 11, 2003 · Not classified · Z-0395-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0414-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0404-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0409-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0408-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0398-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0455-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0451-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0401-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0460-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0406-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0394-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0399-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0419-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0416-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0413-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0456-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0415-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0407-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0405-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0462-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0410-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0397-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0461-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0400-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0458-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0411-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0417-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0391-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0418-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0450-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0402-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0454-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0452-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0453-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0392-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0457-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0459-04: The lag screw may migrate to the femoral head or into the abdominal cavity. - Dec 11, 2003 · Not classified · Z-0390-04: The lag screw may migrate to the femoral head or into the abdominal cavity. ## Indications for use The Trochanteric 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. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures. Source page: https://510kreport.com/device/K013563 Methodology: https://510kreport.com/methodology