# K012190: Aos Modular Femoral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: Sep 24, 2001 after 73 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: 1 generation back to K971135 (1997). 3 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982953: Titanium Intramedullary Nails-Various Styles, Biomet, Inc. (1998) Summary page 2.
- K971135: Magellan Intramedullary Femoral Nail System, Wrightmedicaltechnologyinc (1997) Summary page 2.
- K003797: Ace Aim TTC Fusion Nail, DePuy Orthopaedics, Inc. (2000) Summary page 2.

## Most influential descendants
- K123569: Antegrade Femoral Nail (2013), 6 descendants of its own
- K132005: Retrograde Femoral Nail (2013), 4 descendants of its own
- K192003: Auxein Nailing System (2020), 2 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

## Indications for use
The AOS Modular 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 prothesis Fractures distal to a hip joint Nonunions and malunions Fractures resulting from osteoporosis The AOS Femoral Modular Nail is also indicated for use in fusion of the knee and in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia.

Source page: https://510kreport.com/device/K012190
Methodology: https://510kreport.com/methodology