# K192745: DePuy Synthes Trauma Screws

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
- Decided: Nov 26, 2019 after 57 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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). 114 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000066: Synthes (Usa) Locking Condylar Plate (LCP) System, Synthes (Usa) (2000) Summary page 21.
- K001720: Synthes Sacral Bar System, Synthes (Usa) (2000) Summary page 23.
- K011583: Spiked Washer, Synthes (Usa) (2002) Summary page 25.
- K032559: Synthes 4.0MM Titanium (TI.) Locking Screws, Synthes (Usa) (2003) Summary page 27.
- K040765: Synthes 5.0/7.3 MM Cannulated Locking Screws, Synthes (Usa) (2004) Summary page 29.
- K041533: Synthes (Usa) [Synthes} Peri-Prosthetic Screws, Synthes (Usa) (2004) Summary page 31.
- K050683: Synthes (Usa) 3.5MM Conical Screws, Synthes (Usa) (2005) Summary page 33.
- K052483: Synthes (Usa) Spherical Washers, Synthes (Usa) (2005) Summary page 35.
- K061621: Synthes (Usa) 6.5 MM Cancellous Screws, Synthes (Usa) (2006) Summary page 37.
- K081071: Synthes 6.5MM Midfoot Fusion Bolt, Synthes (Usa) (2008) Summary page 39.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 41.
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 43.
- K180541: DePuy Synthes 2.0 mm Quick Insertion Screws, Synthes USA Products, LLC (2018) Summary page 47.
- K961413: Synthes Anatomical Locking Plate System, Synthes (Usa) (1996) Summary page 49.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 51.
- K974537: Synthes Cannulated Angle Blade Plate (Cabp) System, Synthes (Usa) (1998) Summary page 53.

## Most influential descendants
- K211783: TriMed Threaded Intramedullary Nail System (2021), 2 descendants of its own
- K230749: TriMed Threaded Intramedullary Nail System (2023), 1 descendant of its own
- K220319: Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System (2022), 1 descendant of its own
- K233912: ARIX Cannulated Screw System (2024), 0 descendants of its own
- K234040: TriMed Threaded Intramedullary Nail System (2024), 0 descendants of its own

## Indications for use
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. The DePuy Synthes Sacral Bar System is intended for fixation of fractures of the posterior pelvis, in areas of the posterior superior iliac spine and posterior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint. The DePuy Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically re-adaptation of torn or avulsed ligaments. The DePuy Synthes 4.0 mm Titanium Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia. The DePuy Synthes 5.0/7.3 mm Cannulated Locking Screws are intended to be used with existing DePuy Synthes LCP® plating systems for the fixation of various long bones, such as the femur. The DePuy Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with DePuy Synthes Locking Plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of nonunions or malunions. The DePuy Synthes 3.5 mm Conical Screws are intended to be used with existing DePuy Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone. The DePuy Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large (long) bone and bone fragments. In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis). DePuy Synthes 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses. DePuy Synthes 6.5 mm Midfoot Fusion Bolt is indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. The DePuy Synthes 1.0mm, 1.3mm, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2. 7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2. 7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21 years) when used with the DePuy Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the DePuy Synthes Ti Wrist Fusion Plate (K023879). The DePuy Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or mal unions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula and the bones of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis of the foot and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments; and the bones of the hand and foot, in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis. The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis. The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures, avulsions, non-unions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, osteotomies, non-unions, and malunions of small bones and small bone arthrodesis in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures, non-unions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bones and bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes 2.0 mm Quick Insertion Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the bones of the forefoot, midfoot, and hand in patients 2 years of age and older in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The DePuy Synthes ALPS is a plate and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula, and femur. The DePuy Synthes 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot. 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.

Source page: https://510kreport.com/device/K192745
Methodology: https://510kreport.com/methodology