# K070444: Aos Tibial Nail

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: Jun 14, 2007 after 119 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: 4 generations back to K951740 (1995). 15 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032097: Depuy Ace Versanail Tibial Nail, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 1.
- (no number) Stryker Trauma T2 Tibial Nail System: named in the summary without a submission number

## Most influential descendants
- K130625: 12MM and 13MM Tibial Nails (2013), 3 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 AOS Tibial Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the tibia. The AOS Tibial Nail System is indicated for long bone fracture fixation of tibial fractures, which may include the following: Transverse, oblique, spiral, segmental and comminuted fractures; Fractures with bone loss and bone transport; Open and closed fractures, pathologic fractures; Corrective osteotomies pseudarthrosis of the tibial shaft" Nonunions, malunions, metaphyseal and epiphyseal fractures.

Source page: https://510kreport.com/device/K070444
Methodology: https://510kreport.com/methodology