# K160553: DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
- Decided: Jun 30, 2017 after 487 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: 14 generations back to K962616 (1996). 190 ancestors in all.
No later device cites it as a predicate yet.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000089: Synthes 4.0 and 5.0 MM Locking Screws, Synthes (Usa) (2000) Summary page 57.
- K000558: Synthes (Usa) Wrist Fusion Plates (WFP), Synthes (Usa) (2000) Summary page 59.
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 61.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 63.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000) Summary page 65.
- K010766: Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate, Synthes (Usa) (2001) Summary page 67.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 69.
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 71.
- K031725: Synthes TI-15 MO Locking Distal Radius Plating System, Synthes (Usa) (2003) Summary page 73.
- K032032: Synthes (Usa) LCP Proximal Femur Hook Plates, Synthes (Usa) (2003) Summary page 75.
- K033071: Synthes (Usa) Cannulated Titanium Humeral Nail System, Synthes (Usa) (2003) Summary page 77.
- K040762: Synthes (Usa) Tibial Nail System EX, Synthes (Usa) (2004) Summary page 79.
- K041911: Synthes (Usa) LCP Curved Plates, Synthes (Usa) (2004) Summary page 81.
- K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension), Synthes (Usa) (2004) Summary page 83.
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 85.
- K052483: Synthes (Usa) Spherical Washers, Synthes (Usa) (2005) Summary page 87.
- K053105: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Synthes (Usa) (2005) Summary page 89.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 91.
- K070946: Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates, Synthes (Usa) (2007) Summary page 93.
- K071184: Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System, Synthes (Usa) (2007) Summary page 95.
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System, Synthes (Usa) (2008) Summary page 97.
- K082148: Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension, Synthes (Usa) (2008) Summary page 99.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 101.
- K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates, Synthes (Usa) (2009) Summary page 103.
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 105.
- K091644: Synthes (Usa) 2.4MM LCP Volar Column Distal Radius Plates, Synthes (Usa) (2009) Summary page 107.
- K092247: Synthes Locking Hand Plates, Synthes (Usa) (2009) Summary page 109.
- K092556: Synthes (Usa) 2.4MM VA-LCP Two-Column Narrow Volar Distal Radius, Synthes (Usa) (2009) Summary page 111.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 40.
- K102694: 2.4MM VA-LCP Dorsal Distal Radius Plates, Synthes (Usa) (2010) Summary page 115.
- K103002: Synthes Multiloc Proximal Humeral Nailing System, Synthes (Usa) (2011) Summary page 118.
- K103243: 2.4MM VA-LCP Intercarpal Fusion System, Synthes (Usa) (2011) Summary page 120.
- K110125: 2.4 MM VA-LCP Volar Rim Distal Radius System, Synthes USA (2011) Summary page 122.
- K111230: Synthes 3.5MM Low Profile Cortical Screw, Synthes (USA) Products, LLC (2011) Summary page 124.
- K112085: Synthes LCP Pediatric Plate Systems, Synthes (USA) Products, LLC (2011) Summary page 126.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 128.
- K113364: 2.7MM LCP Ulna Osteotomy System, Synthes (USA) Products, LLC (2012) Summary page 130.
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System, Synthes (USA) Products, LLC (2012) Summary page 132.
- K120807: Synthes Multiloc Humeral Nailing System, Synthes USA Products, LLC (2012) Summary page 134.
- K120854: Synthes VA LCP Ankle Trauma System, Synthes USA (2012) Summary page 136.
- K121601: Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate, Synthes USA (2012) Summary page 138.
- K131186: Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot System, Synthes (USA) Products, LLC (2013) Summary page 140.
- 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). Cleared while this submission was under review Summary page 142.
- K162124: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins, DePuy Synthes (2017). Cleared while this submission was under review Summary page 146.
- K914546: Angled Blade Plate, Synthes (Usa) (1991) Summary page 148.
- K933518: Synthes Unreamed Humeral Nail (Urhn), Synthes (Usa) (1994) Summary page 150.
- K971783: Synthes Elastic Intramedullary Nail (Ein) System, Synthes (Usa) (1997) Summary page 152.
- K982732: Synthes (Usa) Distal Radius Plate System (DRPS), Synthes (1998) Summary page 154.
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 156.
- K992348: Synthes Spiral Blade for Humeral Nail (SBHN), Synthes (Usa) (1999) Summary page 158.

## Indications for use
The DePuy Synthes 4.0 mm and 5.0 mm Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails. The DePuy Synthes Wrist Fusion Plates are intended for wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities. The DePuy Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions. The DePuy Synthes Small Fragment DCL system is indicated for the fixation of fractures, osteotomies. and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone. The 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 Compression Plate (LCP) System - T Plate are 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 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 Stainless Steel Modular Hand System is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones. The DePuy Synthes Ti-15 Mo Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. 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. The DePuy Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include: Diaphyseal fractures of the humeral shaft, Fractures of the proximal humerus, Proximal humeral fractures with diaphyseal extension, Impending pathologic fractures, and Malunions and nonunions. The DePuy Synthes Tibial Nail System Ex is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post -isthmic fractures; and tibial malunions and non-unions. 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 Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. The DePuy Synthes LCP Wrist Fusion Plates are intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities. 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). The DePuy Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. 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 LCP Dia-Meta Volar Distal Radius Plates are indicated for fractures, osteotomies, and non-unions of the radius and other small bones. The DePuy Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The DePuy Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. The DePuy Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. The DePuy Synthes 3.5 mm Locking Compression Plate CLCP) System: The Synthes 3.5 mm LCP is indicated for fixation offractures, osteotomies and non-unions ofthe clavicle, scapula, olectranon, 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 CLCP) System: The Synthes 4.5 LCP is indicated for fixation ofvarious 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 flXation of diaphyseal and metaphyseal areas of long bones in pediatric patients. The DePuy Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The DePuy Synthes 1.5 mm Mini Fragment LCP System is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments, particularly in osteopenic bone. The DePuy Synthes 2.4 mm LCP Volar Column Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures of and osteotomies of the distal radius and other small bones. The DePuy Synthes Locking Hand Plates are intended for fixation of fractures, osteotomies, non-unions, replantations and fusions of small bones and small bone fragments, particularly in osteopenic bone. The DePuy Synthes 2.4 mm VA-LCP Two-Column Narrow Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The DePuy Synthes 2.4 mm / 2.7 mm VA-LCP Forefoot / Midfoot System is indicated for fixation of osteotomies, fusions, fractures, non unions, mal unions and replantations of small bones and small bone fragments in adult and adolescent (12- 21 years) patients, including the foot and ankle, and particularly in osteopenic bone. The DePuy Synthes 2.4 mm LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra:articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The 2.4 mm LCP Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The DePuy Synthes 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The DePuy Synthes 2.4mm Variable Angle LCP Two-Column Narrow Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The DePuy Synthes Variable Angle LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The DePuy Synthes Synthes Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The DePuy Synthes Ti-15Mo Locking Distal Radius Plating System Distal System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The DePuy Synthes MultiLoc Proximal Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures. The DePuy Synthes 2.4 mm V A-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand including: hamate, capitate, lunate, and triquetrum, for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to: Osteoarthritis, Rheumatoid arthritis, Post-traumatic or degenerative wrist arthritis, Carpal instability. The DePuy Synthes 2.4 mm Variable Angle LCP Volar Rim Distal Radius Plates are indicated for fixation of complex intra- and extra-articular fractures of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intraarticular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius. The DePuy Synthes 3.5 mm Low Profile Cortical Screws are intended for fixation of ITactures, 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 the screw fixation. The DePuy Synthes Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults. Specific indications for the 100°, 120°, 130°, 140°, 150° plates include: • Varus, valgus, rotational and/or shortening osteotomies • Femoral neck and/or pertrochanteric fractures • Proximal metaphyseal fractures • Diaphyseal fractures • Pathologic fractures • Prophylactic use for impending pathologic fractures Specific indications for the 90° plates include: • Varus, valgus, rotational and/or shortening osteotomies • Femoral neck and/or penrochanteric fractures • Proximal and distal metaphyseal fractures • Diaphyseal fractures • Pathologic fractures • Prophylactic usc for impending pathologic fractures The DePuy Synthes 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm, and 2.4 mm 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 2.7 mm 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 Synthes 2.7 mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21 years) when used with the Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879). The DePuy Synthes 3.5 mm and 4.0 mm 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 4.5 mm 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 2.7 mm LCP Ulna Osteotomy System is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. The 2.7 mm LCP Ulna Osteotomy System is indicated for use in both adults 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 VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, mal unions, tibial osteotomies and osteopenic bone. The DePuy Synthes MultiLoc Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures. The DePuy Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically, • Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, non unions, mal unions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, • Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and • Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, non unions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula. The DePuy Synthes 2.7/3.5 mm Variable Angle LCP Ankle Trauma System is intended Indications for Use for fixation of the ankle and is indicated in adults and adolescents ( 12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically, • Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, non unions, mal unions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia. • Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, non unions, mal unions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia, • Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and • Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, mal unions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula. The DePuy Synthes 2.7 mm and 3.5 mm Variable Angle LCP Midfoot/Hindfoot System is indicated for fixation of osteotomie, fusions, fractures, nonunions, malunions and replantations of small bones and small one fragments in adult and adolescent (12 -21 years) patients, including the foot and ankle, and particularly in osteopenic bone. The DePuy Synthes 3.5 mm Low Profile Cortical Screws and the Synthes 3.5 mm Cortex Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, 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 the 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; 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 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 Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant. The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws. The DePuy Synthes Angled Blade Plate is intended for use in femoral fractures and osteotomies. More specifically, the primary intended uses are as follows: • fractures of the distal and proximal femur • femoral neck and pertrochanteric fractures • intertrochanteric femoral osteotomies • repositioning osteotomy (femoral neck) The DePuy Synthes Unreamed Humeral Nail (URHN) is generally indicated for Humeral shaft fractures. Specifically, • Acute humeral shaft fractures; • Pathologic or impending pathologic fractures; • Non and malunions of the humeral shaft. The DePuy Synthes EIN is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. The DePuy Synthes Distal Radius Plate System is intended for fixation of fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect. The 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 Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus. The DePuy Synthes Kirschner (K-) Wires and Guide Wires are indicated for use in open and percutaneous fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, for implantation through the skin, and as traction pins so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K160553
Methodology: https://510kreport.com/methodology