# K131365: T2 Tibial Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Oct 10, 2013 after 150 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951740 (1995). 13 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003018: Titan Tibial Nail, Howmedica Osteonics Corp. (2000) Summary page 1.
- K111667: Synthes Suprapatellar Insertion Instruments, Synthes (Usa) (2011)

## 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
- 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
- K171108: AUTOBAHN Nailing System (2017), 2 descendants of its own

## Recalls of this device
- May 27, 2021 · Class II · Z-2170-2021: The devices have a different inner diameter than the diameter specified on the outer box label.
- May 27, 2021 · Class II · Z-2171-2021: The devices have a different inner diameter than the diameter specified on the outer box label.
- Jan 21, 2016 · Class II · Z-0882-2016: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
- Jul 24, 2014 · Class II · Z-0065-2015: Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.

## Indications for use
The T2 Tibial Nailing System 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 compressed locked. The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: Open and closed tibial fractures Pseudoarthodosis and correction osteotomy Pathologic fractures, impending pathologic fractures, and tumor resections Nonunion and malunion

Source page: https://510kreport.com/device/K131365
Methodology: https://510kreport.com/methodology