# K191598: AOS ES Retrograde Femoral Nail

- Pathway: 510(k) (Special)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: Jul 18, 2019 after 31 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: 5 generations back to K970097 (1997). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132005: Retrograde Femoral Nail, Advanced Orthopaedic Solutions, Inc. (2013) Summary page 4.
- K103533: ES Trochanteric Nail, Left and Right, 10MM, Advanced Orthopaedic Solutions, Inc. (2011) Summary page 4.

## Indications for use
The AOS ES™ 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.

Source page: https://510kreport.com/device/K191598
Methodology: https://510kreport.com/methodology