# K123569: Antegrade Femoral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: May 24, 2013 after 185 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: 2 generations back to K971135 (1997). 4 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012190: Aos Modular Femoral Nail, Advanced Orthopaedic Solutions, Inc. (2001) Summary page 1.

## Most influential descendants
- K132005: Retrograde Femoral Nail (2013), 4 descendants of its own
- K141228: Aos 6.5MM Captured, Fully Threaded Cancellous Screw (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
- K230257: Arthrex Intramedullary Nails (2023), 1 descendant of its own
- K243890: Arthrex Intramedullary Nails (2025), 0 descendants of its own

## Indications for use
The AGS 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 intraarticular extension * Ipsilateral femur fractures * Bone lengthening * Fractures proximal to a total knee arthroplasty or prosthesis * Fractures distal to a hip joint * Nonunions and malunions * Fractures resulting from osteoporosis

Source page: https://510kreport.com/device/K123569
Methodology: https://510kreport.com/methodology