# K190750: DePuy Synthes Plates and Screws Portfolio

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: Jun 21, 2019 after 88 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: 10 generations back to K962616 (1996). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162124: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins, DePuy Synthes (2017) Summary page 34.
- K093928: Synthes 3.5MM Quadrilateral Surface Plates, Synthes (Usa) (2010) Summary page 36.
- K083213: Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates, Synthes (Usa) (2008) Summary page 38.
- K082624: Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates, Synthes (Usa) (2008) Summary page 40.
- K081353: Synthes (Usa) Tomofix Medial Distal Femur Plates, Synthes (Usa) (2008) Summary page 42.
- K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008) Summary page 44.
- K071264: Synthes (Usa) 2.4/2.7 MM Locking Foot Module, Synthes (Usa) (2007) Summary page 46.
- K062564: Synthes LCP Distal Femur Plates, Synthes (Usa) (2006) Summary page 48.
- K061940: Synthes LCP Ankle Arthrodesis Plates, Synthes (Usa) (2006) Summary page 50.
- K052390: Synthes LCP Proximal Tibia Plates Line Extension, Synthes (Usa) (2005) Summary page 52.
- K050646: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates, Synthes (Usa) (2005) Summary page 54.
- K050110: Synthes (Usa) LCP Modular Foot Plates, Synthes (Usa) (2005) Summary page 56.
- K033556: Synthes (Usa) LCP Dynamic Helical Hip System, Synthes (Usa) (2004) Summary page 58.
- K032032: Synthes (Usa) LCP Proximal Femur Hook Plates, Synthes (Usa) (2003) Summary page 60.
- K031573: Synthes 3.5 MM Low Profile Pelvic Reconstruction Plate, Synthes (Usa) (2003) Summary page 62.
- K030858: Synthes (Usa) LCP Proximal Femur Plate and Screws, Synthes (Usa) (2003) Summary page 64.
- K030597: Synthes 3.5MM Titanium LCP Proximal Tibia Plates, Synthes (Usa) (2003) Summary page 66.
- K023802: Synthes 4.5 MM Titanium LCP Proximal Tibia Plating System, Synthes (Usa) (2003) Summary page 68.
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 70.
- K011978: Synthes LCP Proximal Tibia Plate, Synthes (Usa) (2001) Summary page 72.
- K010321: Modular Foot System - 2.7 MM Module, Synthes (Usa) (2001) Summary page 74.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 76.
- K000066: Synthes (Usa) Locking Condylar Plate (LCP) System, Synthes (Usa) (2000) Summary page 80.
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 82.
- K983787: Synthes Proximal Tibia Plating System, Synthes (Usa) (1999) Summary page 84.
- K964259: Synthes (Usa) DDHS/DCS System Modification, Synthes (Usa) (1997) Summary page 86.
- K963325: Synthes Titanium (TI) Alloy High Tibial Osteotomy (Hto) System, Synthes (Usa) (1997) Summary page 88.
- K791619: Dynamic Hip Screw, Synthes (Usa) (1979) Summary page 90.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 92.

## Indications for use
The DePuy Synthes Modular Mini Fragment LCP System is intended 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. The DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions. DePuy Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates. The DePuy Synthes 2.7 mm / 3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone. DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia. DePuy Synthes TornoFiX Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis. The DePuy Synthes LCP Distal Tibia T Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone. The DePuy Synthes 2.4/2.7 mm Locking Foot Module is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including the foot and ankle, particularly in osteopenic bone. DePuy Synthes LCP Distal Femur Plates are intended 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. DePuy Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia. The DePuy Synthes LCP Proximal Tibia System is intended for treatment of nonunions, malunions, osteopenic bone, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. The DePuy Synthes 3.5 / 4.5mm LCP Medial Proximal Tibia Plates are intended 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. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies. The DePuy Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle. The DePuy Synthes LCP Dynamic Helical Hip System is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. The DePuy Synthes LCP Proximal Femur Hook Plates are intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur. DePuy Synthes 3.5 Low Profile Pelvic Reconstruction Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula. DePuy Synthes LCP Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur. DePuy Synthes 3.5mm Titanium LCP Proximal Tibia Plate is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The DePuy Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar, combination of lateral wedge and depression, and fractures with associated shaft fracture. The DePuy Synthes Locking Compression Plate (LCP) System 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. The DePuy Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the DePuy Synthes Small Fragment LCP System. The DePuy Synthes LCP Proximal Tibia Plate is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. The DePuy Synthes Modular Foot System - 2.7 mm Module is intended for fractures, osteotomies, fusions and replantations of small bones including the foot, ankle, and hand. DePuy Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures. DePuy Synthes Modular Foot System is intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand. The DePuy Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions. DePuy Synthes Locking Calcaneal Plates are indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures. The DePuy Synthes Proximal Tibia Plating System is intended for non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. DePuy Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. DePuy Synthes Titanium Alloy High Tibial Osteotomy (HTO) System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component. It utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The DePuy Synthes DHS is indicated for the following fractures of the proximal femur: « Intertrochanteric fractures « Subtrochanteric fractures » Basilar neck fractures The DHS is indicated for stable fractures, and unstable fractures in which a stable medial buttress can be reconstructed. The DePuy Synthes Modular Mini Fragment LCP System is intended 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.

Source page: https://510kreport.com/device/K190750
Methodology: https://510kreport.com/methodology