# K150649: G3 Active Plate Large Fragment System

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Fracture Care, Inc.
- Decided: Apr 30, 2015 after 49 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962616 (1996). 55 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142938: G3 Active Plate Large Fragment System, Genesis Fracture Care, Inc. (2014) Summary page 5.

## Most influential descendants
- K152242: G3¿ Active Plate® Large Fragment System (2015), 1 descendant of its own
- K160633: G3(TM) Active Plate (R) Small Fragment System (2016), 0 descendants of its own

## Indications for use
The system is intended for use in adult and pediatric cases (subpopulation: transitional adolescent B (18 years to <21 years) requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed and open fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, and femur, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K150649
Methodology: https://510kreport.com/methodology