# K230257: Arthrex Intramedullary Nails

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 17, 2023 after 167 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K970097 (1997). 102 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133081: Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade Femoral Nails, Retrograde Femoral N, Advanced Orthopaedic Solutions, Inc. (2013) Summary page 6.
- K202099: AOS Galileo™ Trochanteric Nail System, Advanced Orthopaedic Solutions, Inc. (2020) Summary page 6.
- K141228: Aos 6.5MM Captured, Fully Threaded Cancellous Screw, Advanced Orthopaedic Solutions, Inc. (2014) Summary page 6.
- K132005: Retrograde Femoral Nail, Advanced Orthopaedic Solutions, Inc. (2013) Summary page 6.
- K130625: 12MM and 13MM Tibial Nails, Advanced Orthopaedic Solutions, Inc. (2013) Summary page 6.
- K123569: Antegrade Femoral Nail, Advanced Orthopaedic Solutions, Inc. (2013) Summary page 6.
- K103533: ES Trochanteric Nail, Left and Right, 10MM, Advanced Orthopaedic Solutions, Inc. (2011) Summary page 6.
- K070444: Aos Tibial Nail, Advanced Orthopaedic Solutions, Inc. (2007) Summary page 6.
- K021008: Advanced Orthopaedic Solutions Trochanteric Nail, Advanced Orthopaedic Solutions, Inc. (2002) Summary page 6.

## Most influential descendants
- K243890: Arthrex Intramedullary Nails (2025), 0 descendants of its own

## Indications for use
The antegrade femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections, Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis. The retrograde femoral nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures and tumor resections, Supracondylar fractures, including those with severe comminution and intra articular extension, Ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis. The tibial nail system is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the tibia. The tibial nail system is indicated for long bone fracture fixation of tibial fractures, which may include the following: traverse, oblique, spiral, segmental and comminuted fractures; fractures with bone loss and bone transport; open and closed fractures, pathologic fractures; corrective osteotomies; pseudarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures. The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, peritrochanteric 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. The ES trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

Source page: https://510kreport.com/device/K230257
Methodology: https://510kreport.com/methodology