# K093474: Depuy Fracture and Fusion Plating System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 2, 2010 after 88 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 4 cite it directly.
0 of 17 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 no predicate by number.

## Most influential descendants
- K132898: A.L.P.S. Calcaneal Plating System (2013), 11 descendants of its own
- K171808: TDM Plate and Screw System (2018), 6 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K221150: Advanced Bone Plate (2023), 1 descendant of its own
- K190391: TDM Plate and Screw Systems (2019), 1 descendant of its own

## Recalls of this device
- Oct 25, 2017 · Class II · Z-1306-2018: The drill guides were manufactured with the incorrect color anodization.
- Jun 4, 2015 · Class II · Z-2046-2015: The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the pl

## Indications for use
The DePuy Fracture and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Source page: https://510kreport.com/device/K093474
Methodology: https://510kreport.com/methodology