# K180310: DePuy Synthes Trauma Orthopedic Plates and Screws - Pathway: 510(k) (Traditional) - Applicant: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. - Decided: Nov 1, 2018 after 269 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). 112 ancestors in all. 4 later devices descend from it; 3 cite it directly. 0 of 117 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K792291: Synthes Reconstructive Plates 'Y' Plates, Synthes (Usa) (1979) Summary page 33. - K961413: Synthes Anatomical Locking Plate System, Synthes (Usa) (1996) Summary page 35. - K974537: Synthes Cannulated Angle Blade Plate (Cabp) System, Synthes (Usa) (1998) Summary page 37. - K992837: 3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated LC-Abp), Synthes (Usa) (1999) Summary page 39. - K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 41. - K010766: Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate, Synthes (Usa) (2001) Summary page 43. - K011334: Synthes Curved Reconstruction Plate, Synthes (Usa) (2001) Summary page 45. - K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 47. - K011815: Synthes LCP Proximal Humerus Plates, Synthes (Usa) (2001) Summary page 49. - K020602: Synthes Pilon Plate, Synthes (2002) Summary page 51. - K023941: Synthes Tomofix Osteotomy System, Synthes (Usa) (2003) Summary page 53. - K031178: Synthes (Usa) 3.5 MM Broad LCP & 4.5 MM LCP Distal Humerus Plates, Synthes (Usa) (2003) Summary page 55. - K031677: Synthes (Usa) Calvicle Hook Plate, Synthes (Usa) (2003) Summary page 57. - K033805: Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates, Synthes (Usa) (2004) Summary page 59. - K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 61. - K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 63. - K041911: Synthes (Usa) LCP Curved Plates, Synthes (Usa) (2004) Summary page 65. - K042377: Synthes Low Profile Reconstruction Plates, Synthes (Usa) (2004) Summary page 67. - K061973: Synthes 3.5MM Spring Plate, Synthes (Usa) (2006) Summary page 69. - K082072: Synthes (Usa) 3.5MM LCP Hook Plate, Synthes (Usa) (2008) Summary page 71. - K082625: Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates, Synthes (Usa) (2008) Summary page 73. - K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 75. - K083573: Synthes (Usa) 3.5MM Locking Attachment Plates, Synthes (Usa) (2009) Summary page 77. - K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 79. - K101536: 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System, Synthes (Usa), LLC (2010) Summary page 81. - K111540: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2011) Summary page 83. - K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 85. - K120717: Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates), Synthes USA (2012) Summary page 87. - K141796: Depuy Synthes Tomofix Osteotomy System, Synthes (USA) Products, LLC (2014) Summary page 89. - K163046: DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long, DePuy Synthes (2017) Summary page 91. ## Most influential descendants - K243995: Arthrex Humeral Plating System and Cerclage Button (2025), 1 descendant of its own - K190391: TDM Plate and Screw Systems (2019), 1 descendant of its own - K260353: Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (2026), 0 descendants of its own - K241128: TDM Plate and Screw System (2024), 0 descendants of its own ## Indications for use The DePuy Synthes Reconstructive Plates 'Y' Plates are indicated for pelvic and acetabular reconstructive surgery and the reduction of fractures in the distal humerus, the clavicle, and the scapula. The DePuy Synthes Anatomical Locking Plate System is indicated to treat fractures (including but not limited to) the radius, ulna, humerus, tibia, fibula, femur. The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia. Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone, and nonunions and malunions. Distal tibia fractures include acute fractures, fractures in osteopenic bone, and nonunions and malunions. The DePuy Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia. The DePuy Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. Also for use in fixation of osteopenic bone and fixation of non-unions or malunions. The DePuy Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in fixation of osteopenic bone and fixation of non-unions and malunions. The DePuy Synthes Curved Reconstruction Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System. The DePuy Synthes One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System. The DePuy Synthes LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. The DePuy Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia. DePuy Synthes TomoFix Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia and lateral distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis. The DePuy Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plates are indicated for fractures of the distal humerus. The DePuy Synthes Clavicle Hook Plate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. The DePuy Synthes 3.5 / 4.5 LCP Metaphyseal Plate is intended for fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions. The DePuy Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, commninuted supra-condylar fractures, osteotomies, and non-unions of the distal humerus. The DePuy Synthes LCP Proximal Humerus Plate, Long is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. The DePuy Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions. The DePuy Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including: supracondylar, intra-articular and extra-articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur. The DePuy Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula. The DePuy Synthes 3.5 mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula. The DePuy Synthes 3.5 mm LCP Hook Plate is indicated for fractures, osteotomies and non-unions of small bones including the ulna, radius, tibia and fibula, particularly in osteopenic bone. The DePuy Synthes 3.5 mm LCP Periarticular Proximal Humerus Plates are indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. The DePuy Synthes 3.5 mm Locking Compression Plate (LCP) System: The DePuy Synthes 3.5 mm LCP is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients. These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. The DePuy Synthes 4.5 mm Locking Compression Plate (LCP) System: The DePuy Synthes 4.5 mm LCP is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. The DePuy Synthes 3.5mm Locking Attachment Plate is intended for use with DePuy Synthes LCP plates to augment the stabilization of fractures, including periprosthetic fractures and fractures in the presence of intramedullary implants, in the femur, tibia and humerus, particularly in osteopenic bone. The DePuy Synthes 3.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients. The DePuy Synthes 4.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients. The DePuy Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. The DePuy Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system. The DePuy Synthes 3.5 mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system. The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused or in which the growth plates will not be crossed by the plate system. Specifically, - Distal humerus plates are indicated for intra-articular fractures, commninuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. - Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna. The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused or in which the growth plates will not be crossed by the plate system. Specifically, - Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. - Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna. The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia. Specifically, -The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and close-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia -The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the lateral proximal tibia -The TOMOFIX Lateral Distal Femur Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur -The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur The DePuy Synthes 2.4/2.7 mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long is intended for intra- and extra-articular fractures, osteotomies, nonunions and malunions of the distal radius, with or without extension into the radial diaphysis in adults and adolescents (12-21) where the growth plates have fused or will not be crossed, and the following adolescent distal radius fractures: - Intra-articular fractures exiting the epiphysis - Intra-articular fractures exiting the metaphysis - Physeal crush injuries - Any injuries which cause growth arrest to the distal radius Source page: https://510kreport.com/device/K180310 Methodology: https://510kreport.com/methodology