# K142135: Reduce Fracture Plating System Line Extension

- Pathway: 510(k) (Special)
- Applicant: Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
- Decided: Aug 28, 2014 after 24 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022325 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140876: View Plating System,Reduce Fracture Plating System,Bone Screw, Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic (2014) Summary page 4.

## Recalls of this device
- Apr 6, 2018 · Class II · Z-2117-2018: Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not pr
- Apr 6, 2018 · Class II · Z-2128-2018: Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not pr
- Apr 6, 2018 · Class II · Z-2116-2018: Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not pr
- Apr 6, 2018 · Class II · Z-2125-2018: Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not pr
- Apr 6, 2018 · Class II · Z-2118-2018: Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not pr

## Indications for use
EDGE Orthopaedics’ REDUCE® Fracture Plating System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws. Plates and screws are intended for single use only. Screws are not intended for use in the spine.

Source page: https://510kreport.com/device/K142135
Methodology: https://510kreport.com/methodology