# K021027: S2 Tibial 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 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 Tibial Nail System: named in the summary without a submission number

## Most influential descendants
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K161327: Syntec Humeral Nail System (2017), 3 descendants of its own
- K181296: Syntec Femoral Nail System (2019), 2 descendants of its own
- K141228: Aos 6.5MM Captured, Fully Threaded Cancellous Screw (2014), 2 descendants of its own
- K230257: Arthrex Intramedullary Nails (2023), 1 descendant of its own

## Indications for use
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

Source page: https://510kreport.com/device/K021027
Methodology: https://510kreport.com/methodology