# K021008: Advanced Orthopaedic Solutions Trochanteric Nail

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: Jun 20, 2002 after 84 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 12 (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). 12 ancestors in all.
13 later devices descend from it; 7 cite it directly.
0 of 26 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)
- K993670: Modified Long Length Gamma Nail, Howmedica Osteonics Corp. (1999) Summary page 1.
- K012158: Modification to: Long Length Gamma Nail, Howmedica Osteonics Corp. (2001)
- K013524: Trochanteric Dyax Nail System, Howmedica Osteonics Corp. (2001)
- K912162: Intramedullary Hip Screw, Modification, Smith & Nephew Richards, Inc. (1991) Summary page 1.
- K921786: Intramedullary Hip Screw, Smith & Nephew Richards, Inc. (1992) Summary page 1.
- K954712: Intramedullary Hip Screw (Modification), Smith & Nephew Richards, Inc. (1995) Summary page 1.

## Most influential descendants
- K103533: ES Trochanteric Nail, Left and Right, 10MM (2011), 11 descendants of its own
- K120148: Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw (2012), 6 descendants of its own
- K202099: AOS Galileo™ Trochanteric Nail System (2020), 4 descendants of its own
- K140601: Flow-Nail (2014), 2 descendants of its own
- K133081: Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade Femoral Nails, Retrograde Femoral N (2013), 2 descendants of its own

## Recalls of this device
- Jan 14, 2010 · Not classified · Z-1190-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1187-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1184-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1182-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1188-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1186-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-118-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1189-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1183-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1181-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1191-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t
- Jan 14, 2010 · Not classified · Z-1192-2010: The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If t

## Indications for use
The AOS Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

Source page: https://510kreport.com/device/K021008
Methodology: https://510kreport.com/methodology