# K113409: S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 15, 2012 after 89 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: 3 generations back to K013468 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032579: S2 Nail System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K102992: T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees, Howmedica Osteonics Corp. (2010) Summary page 1.

## Indications for use
S2 Tibial Nail The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked. The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: * Open and closed tibial fractures * Pseudoarthrosis and correction osteotomy * Pathologic fractures, impending pathologic fractures, and tumor resections * Nonunion and malunion S2 Femoral Nail The S2 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 a hip joint * Nonunions and malunions,

Source page: https://510kreport.com/device/K113409
Methodology: https://510kreport.com/methodology