# K112059: T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp

- Pathway: 510(k) (Special)
- Applicant: Stryker
- Decided: Aug 8, 2011 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: 1 generation back to K010801 (2001). 4 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014220: T2 Femoral Nail System, Howmedica Osteonics Corp. (2002) Summary page 1.
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001) Summary page 1.
- K081152: T2 Femoral Nail, Howmedica Osteonics Corp. (2008) Summary page 1.
- K021744: T2 Femoral Nail, Howmedica Osteonics Corp. (2002) Summary page 1.

## Most influential descendants
- K171108: AUTOBAHN Nailing System (2017), 2 descendants of its own
- K150655: OIC Intramedullary Nail System (2015), 2 descendants of its own
- K220659: AUTOBAHN (R) EVO Femoral Nails (2022), 1 descendant of its own
- K181184: OIC Intramedullary Nail System (2018), 1 descendant of its own
- K141103: Intramedullary Nail and Screws-Neonail (2014), 1 descendant of its own

## Indications for use
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may 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 intra-articular extension * Ipsilateral femur fractures * Fractures proximal to a total knee arthroplasty * Fractures distal to hip joint * Nonunions and malunions

Source page: https://510kreport.com/device/K112059
Methodology: https://510kreport.com/methodology
