# K034002: GAMMA3 Nail System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jan 15, 2004 after 22 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 K013468 (2001). 2 ancestors in all.
69 later devices descend from it; 7 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013468: Long Length Dyax Nail, Howmedica Osteonics Corp. (2001) Summary page 1.
- K032244: Gamma 3 Nail System, Howmedica Osteonics Corp. (2003) Summary page 1.

## Most influential descendants
- K043431: GAMMA3 Nail System (2005), 48 descendants of its own
- K102992: T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees (2010), 37 descendants of its own
- K123401: GAMMA3 and T2 Recon Targeting Devices (2013), 20 descendants of its own
- 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

## Recalls of this device
- Jul 23, 2010 · Not classified · Z-2340-2010: The nail has no thread for the set screw hindering insertion.
- Nov 22, 2004 · Not classified · Z-0241-06: The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees inst

## Indications for use
Gamma3 Trochanteric Nail The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Gamma-Ti and Gamma ® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur. Long Length Gamma3 Nail The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intercondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.

Source page: https://510kreport.com/device/K034002
Methodology: https://510kreport.com/methodology