# K081152: T2 Femoral Nail

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 10, 2008 after 48 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.
27 later devices descend from it; 6 cite it directly.
0 of 28 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
- 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
- K112059: T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp (2011), 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
- K213328: Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (2022), 3 descendants of its own
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own

## Indications for use
The T2TM 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 hip joint * Nonunions and malunions

Source page: https://510kreport.com/device/K081152
Methodology: https://510kreport.com/methodology