# K022461: S2 Femoral Nail

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics
- Decided: Aug 22, 2002 after 27 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Femoral Nail System: named in the summary without a submission number

## Recalls of this device
- Oct 4, 2005 · Not classified · Z-0168-06: Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shippi

## Indications for use
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/K022461
Methodology: https://510kreport.com/methodology