# K023267: T2 Supracondylar Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 11, 2002 after 72 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.
38 later devices descend from it; 3 cite it directly.
0 of 39 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 no predicate by number.

## Most influential descendants
- K072161: Biomet Femoral Locking Nail System (2007), 22 descendants of its own
- K200880: T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System (2020), 11 descendants of its own
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K203819: T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System (2021), 7 descendants of its own
- K083726: Pedinail Intramedullary Nailing System (2009), 6 descendants of its own

## Recalls of this device
- Jun 30, 2016 · Class II · Z-2791-2016: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

## Indications for use
The subject device is indicated for 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 distal to a hip joint Nonunions and malunions Reconstruction

Source page: https://510kreport.com/device/K023267
Methodology: https://510kreport.com/methodology