# K160633: G3(TM) Active Plate (R) Small Fragment System

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Fracture Care, Inc.
- Decided: Apr 22, 2016 after 46 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: 13 generations back to K962616 (1996). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060710: Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws, Zimmer, Inc. (2006) Summary page 5.
- K130810: Zimmer Motionloc Screw for Periarticular Locking Plate System, Zimmer, Inc. (2013) Summary page 5.
- K033669: Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws), Smith & Nephew, Inc. (2003) Summary page 5.
- K083032: Peri-Loc Bone Plating and Screw System, Smith & Nephew, Inc. (2009) Summary page 5.
- K152242: G3¿ Active Plate® Large Fragment System, Genesis Fracture Care, Inc. (2015) Summary page 5.
- K142938: G3 Active Plate Large Fragment System, Genesis Fracture Care, Inc. (2014) Summary page 5.

## Indications for use
The G3™ Active Plate® Small 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 and open fractures. The system is indicated for the fixation of long bone fractures including but not limited to fractures of the humerus, tibia, fibula, and radius.

Source page: https://510kreport.com/device/K160633
Methodology: https://510kreport.com/methodology