# K232394: Internal Locking Plate and Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
- Decided: Dec 15, 2023 after 128 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: 4 generations back to K981372 (1998). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 5.
- K073186: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2007) Summary page 6.
- K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 6.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 6.
- K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates, Synthes (Usa) (2009) Summary page 6.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 6.
- K032269: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 6.
- K092812: Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia Plates, Synthes (Usa) (2010) Summary page 6.
- K083213: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 6.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 6.

## Indications for use
Internal Locking Plate and Screw Fixation System is intended for temporary fixation, correction or stabilization of bones in various anatomical regions. 3.5mm LCP Clavicle Plate 3.5mm LCP Clavicle Plate is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. 3.5mm LCP Proximal Humeral Plate LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. 3.5mm LCP Distal Humerus plate 3.5mm LCP Distal Humerus plate is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus. 2.4mm LCP Volar Distal Radius Plate 2.4 mm LCP Volar Distal Radius Plate is indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. 5.0mm LCP Distal Femur Plate 5.0 LCP Distal Femur Plate is indicated for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur. 3.5mm LCP Medial Proximal Tibial Plate 3.5mm LCP Medial Proximal Tibia Plate is indicated to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft. 3.5mm LCP Anterolateral Distal Tibia Plate 3.5mm LCP Anterolateral Distal Tibia Plate is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone. 2.7mm/3.5mm LCP Distal Fibula Plate 2.7mm/3.5mm LCP Distal Fibula Plate is indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone. 2.0mm LCP Condylar Plate 2.0mm LCP condylar Plate is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. 3.5mm Round Hole Reconstruction Locking Plate The 3.5mm Round Hole Reconstruction Locking Plates is indicated for fixation of fractures, osteotomies and non-unions of the pelvis, particularly in osteopenic bone for adult patients.

Source page: https://510kreport.com/device/K232394
Methodology: https://510kreport.com/methodology