# K032579: S2 Nail System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 29, 2003 after 8 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) S2 Nail System: named in the summary without a submission number

## Most influential descendants
- K113409: S2 Femoral a/R Nail S2 Femoral Comression Nail S2 Tibial Nail S2 Tibial Compression Nail (2012), 0 descendants of its own

## Recalls of this device
- May 7, 2020 · Class II · Z-2373-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured

## Indications for use
S2 Tibial Nail The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunion 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/K032579
Methodology: https://510kreport.com/methodology