# K021026: S2 Femoral Nail

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 25, 2002 after 27 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) T2™ Femoral Nail System: named in the summary without a submission number

## Most influential descendants
- K022632: Sign IM Nail (2002), 2 descendants of its own
- K163589: SIGN IM Nail (2017), 0 descendants of its own
- K152757: SIGN Hip Construct (SHC) (2015), 0 descendants of its own

## Recalls of this device
- Oct 4, 2005 · Not classified · Z-0166-06: 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
- Oct 4, 2005 · Not classified · Z-0167-06: 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/K021026
Methodology: https://510kreport.com/methodology