# K141228: Aos 6.5MM Captured, Fully Threaded Cancellous Screw

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: Jul 8, 2014 after 57 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: 6 generations back to K000684 (2000). 80 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123569: Antegrade Femoral Nail, Advanced Orthopaedic Solutions, Inc. (2013) Summary page 1.
- K033329: Depuy Ace Universal and Troch Entry Femoral Nail Systems, Depuy, Inc. (2003) Summary page 1.
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail, I.T.S. GmbH (2014) Summary page 1.

## Most influential descendants
- K230257: Arthrex Intramedullary Nails (2023), 1 descendant of its own
- K243890: Arthrex Intramedullary Nails (2025), 0 descendants of its own

## Indications for use
The AOS Antegradle 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; psilateral 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/K141228
Methodology: https://510kreport.com/methodology