# K101438: T2 Greater Trochanter Nail

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 17, 2010 after 24 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
Longest line of descent: 1 generation back to K010801 (2001). 1 ancestor in all.
25 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001) Summary page 1.

## Most influential descendants
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own
- K180436: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 16 descendants of its own
- K191271: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (2019), 15 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
- K200869: Gamma3 System (2020), 9 descendants of its own

## Recalls of this device
- May 22, 2025 · Class II · Z-1940-2025: Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left n
- May 22, 2025 · Class II · Z-1939-2025: Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left n

## Indications for use
The subject and predicate devices are 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 Ipsilateral femur fractures Fractures proximal to a total knee arthoplasty Nonunions and malunions

Source page: https://510kreport.com/device/K101438
Methodology: https://510kreport.com/methodology