# K130625: 12MM and 13MM Tibial Nails

- Pathway: 510(k) (Special)
- Applicant: Advanced Orthopaedic Solutions, Inc.
- Decided: Mar 28, 2013 after 20 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 K951740 (1995). 16 ancestors in all.
3 later devices descend from it; 2 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)
- K070444: Aos Tibial Nail, Advanced Orthopaedic Solutions, Inc. (2007) 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

## 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; pseudlarthrosis of the tibial shaft; nonunions, malunions, metaphyseal and epiphyseal fractures.

Source page: https://510kreport.com/device/K130625
Methodology: https://510kreport.com/methodology