# K042325: Trochanteric Nail System

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Sep 8, 2004 after 12 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970097 (1997). 6 ancestors in all.
10 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)
- K010780: Trochanteric Nail, DePuy Orthopaedics, Inc. (2001)
- K013563: Long Trochanteric Nail System, DePuy Orthopaedics, Inc. (2001) Summary page 1.

## Most influential descendants
- K100238: HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM (2010), 7 descendants of its own
- K192003: Auxein Nailing System (2020), 2 descendants of its own
- K183162: Affixus Hip Fracture Nail (2018), 2 descendants of its own
- K111663: Trauma Internal Fixation Systems (2012), 1 descendant of its own
- K243761: A.L.P.S. Small Fragment Plating System (2025), 0 descendants of its own

## Recalls of this device
- 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-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-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-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-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-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-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 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-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-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-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

## 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/K042325
Methodology: https://510kreport.com/methodology