# K152242: G3¿ Active Plate® Large Fragment System

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Fracture Care, Inc.
- Decided: Nov 24, 2015 after 106 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: 12 generations back to K962616 (1996). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 60 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.
- K150649: G3 Active Plate Large Fragment System, Genesis Fracture Care, Inc. (2015) Summary page 5.
- K051986: Synthes 4.5 MM LCP Straight Reconstruction Plates, Synthes (Usa) (2005) Summary page 5.
- K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series, Zimmer, Inc. (2004) Summary page 5.
- K042598: Periarticular Locking Plates and Screws, 2357 and 2359 Series, Zimmer, Inc. (2004) Summary page 5.

## Most influential descendants
- K160633: G3(TM) Active Plate (R) Small Fragment System (2016), 0 descendants of its own

## Indications for use
The G3™ Active Plate® Large Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to <21 years) cases requiring stabilizations of mal-unions, non-unions, and osteotomies of long bones, as well as repair of closed, open and periprosthetic 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/K152242
Methodology: https://510kreport.com/methodology