# K123401: GAMMA3 and T2 Recon Targeting Devices

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Jan 23, 2013 after 79 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
Longest line of descent: 3 generations back to K013468 (2001). 5 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043431: GAMMA3 Nail System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K102992: T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees, Howmedica Osteonics Corp. (2010) 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
- K200869: Gamma3 System (2020), 9 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

## Recalls of this device
- Jan 21, 2016 · Class II · Z-0870-2016: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

## Indications for use
The Gamma3 Target Devices are intended for use with the Trochanteric Nail or Long Length Gamma3 Nail. The Gamma3 and T2 Recon Distal Targeting Devices are intended for use with the Long Length Gamma3 Nail and T2 Recon Nail System. Gamma3 Nail System The Troehanteric Gamma3 Nail is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections, while the Long Length Gamma3 Nail inidcation may include fractures resulsting from trauma, nonunion, malunion, pathological fractures, impending pathological fractures, tumor resections and revision procedures. T2 Recon Nail System The T2 Recon Nail System indications include fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

Source page: https://510kreport.com/device/K123401
Methodology: https://510kreport.com/methodology