# K032244: Gamma 3 Nail System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 8, 2003 after 17 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
78 later devices descend from it; 7 cite it directly.
0 of 79 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) Trochanteric Dyax Nail System: named in the summary without a submission number
- (no number) Gamma Nail System: named in the summary without a submission number

## Most influential descendants
- K034002: GAMMA3 Nail System (2004), 69 descendants of its own
- 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

## Recalls of this device
- May 7, 2020 · Class II · Z-2382-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2385-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2386-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2384-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2387-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2379-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2381-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured

## Indications for use
The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Dyax and Gamma Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.

Source page: https://510kreport.com/device/K032244
Methodology: https://510kreport.com/methodology