# K132005: Retrograde Femoral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: Sep 10, 2013 after 71 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: 3 generations back to K971135 (1997). 6 ancestors in all.
4 later devices descend from it; 3 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.
- K023267: T2 Supracondylar Nail System, Howmedica Osteonics Corp. (2002) Summary page 1.
- K123569: Antegrade Femoral Nail, Advanced Orthopaedic Solutions, Inc. (2013) Summary page 1.

## Most influential descendants
- 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
- K191598: AOS ES Retrograde Femoral Nail (2019), 0 descendants of its own

## Indications for use
The AOS 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 Fractures resulting from osteoporosis

Source page: https://510kreport.com/device/K132005
Methodology: https://510kreport.com/methodology