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    K Number
    K180310
    Device Name
    DePuy Synthes Trauma Orthopedic Plates and Screws
    Manufacturer
    Synthes (USA) Products LLC/DePuy Orthopaedics Inc
    Date Cleared
    2018-11-01

    (269 days)

    Product Code
    HRS, HWC, KTT, KTW, LXT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Synthes (USA) Products LLC/DePuy Orthopaedics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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 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 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 / 4.5mm LCP® Metaphyseal Plate is intended for the 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 nonunions 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, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which 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. Specifically, Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures. malunions and non-unions of the distal humerus. Olecranon and Proximal ulna plates are indicated for fractures, 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
    Device Description
    The 3.5 mm Reconstruction Plate is available in multiple lengths. It has a smooth underside, is notched between the screw holes and can be adjusted (contoured) in three dimensions. The screw holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole, and accept 3.5 mm cortex screws. The 4.5 mm Reconstruction Plate has a smooth underside, is notched between the screw holes and can be adjusted (contoured) in three dimensions. The oval holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole which allows 25° longitudinal and 7° lateral angulation of screws. It is available in multiple lengths and accepts 4.5 mm cortex and 6.5 mm cancellous screws. The 3.5 mm Curved Reconstruction Plate is available in multiple lengths. It has a smooth underside and is notched between screw holes and can be adjusted (contoured) in three dimensions. The screw holes are designed to provide limited bidirectional compression of the fracture via the tapered entrance of the hole and accept 3.5 mm cortex screws. The Anatomical Locking Plate System utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical fixation. The plates are available with and without an anatomically contoured head, in a variety of sizes. The head of the screw has a round cross section with a conical underside to fit into the plate. The underside has a tapered thread to match the design of the holes in the plate. The screws are available in thread diameters from 3 mm to 5 mm, in a variety of lengths. The CABP is a straight plate with a blade at the head to allow for better fixation in the head of the humerus or in the distal tibia. The blade of the plate is cannulated to fit over a guide wire, allowing for the adjustment of the wire placement several times without adversely affecting the final result. There are cuts in the undersurface of the plate the surface area of the plate in contact with bone. The area of contact between the plate and the bone is decreased in an effort to reduce damage to the cortical blood supply under the plat, and resultant reduction in damage-induced porosis and remodeling of the bone near the plate undersurface. Plate undercuts also make the bending properties of the plate more uniform, which facilitate contouring. The plate has round and dynamic compression screw holes, accepts 4.5mm and 6.5 mm screws, is available in multiple blade lengths, and is manufactured from stainless steel and commercially pure titanium. The DePuy Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixation and rotational control for fractures of the proximal humerus and distal tibia. The plates feature a low profile limited contact dynamic compression plate (LC-DCP®) design and dynamic compression unit (DCU) screw holes. The blade portion of the plate is cannulated to accept a 2.0 mm guide wire. The plates are available in various sizes to accommodate varying patient anatomy. The Large Fragment DCL system consists of limited-contact profile plates in broad and narrow sizes, which include combination dynamic compression/locking screw holes. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, and 5.0 mm locking screws. This device is manufactured in either stainless steel or titanium. The DePuy Synthes Locking Compression Plate (LCP) System - T Plate is a buttress plate and screw system. The primary feature of the plate is round holes combined with locking screw holes. The locking screws form a locked, fixed angle construct with the plate, while the standard screws facilitate reduction and create compression between the plate and bone. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0 mm locking screws. The DePuy Synthes Curved Reconstruction Plate line extension is a pre-curved version of the currently marketed Straight Locking Reconstruction Plate. Both of these plates will be included as part of the DePuy Synthes Small Fragment DCL System. Both the curved and straight plates have the same intended use and there is no change in safety or efficacy. The DePuy Synthes One-Third Tubular DCL Plate line extension is a threaded version of the currently marketed Synthes Third Tubular Plate. The threaded plates will accept locking screws and therefore can be included as part of the Small Fragment DCL System. The new plates have the same intended use as other plates in the system and there is no change in safety or efficacy. The DePuy Synthes LCP Proximal Humerus Plates are designed to match the anatomy of the proximal humerus. These plates can be applied to either the right or left humerus. The proximal portion of each plate has threaded holes that accept 3.5 mm or 2.7 mm screws. The distal portion of the plate has combination holes that allow the option of using 3.5 mm locking or cortex screws, or 4.0 mm cancellous screws to accomplish plate fixation. These plates will be offered as an addition to the DePuy Synthes Small Fragment LCP (formerly DCL) System. The DePuy Synthes Pilon Plate is a metal plate that offers screw to plate locking designed for various fracture modes of the distal end of the tibia. The TomoFix™ Osteotomy System consists of five different titanium plates with locking and combination holes. There are two plates (left and right) for the lateral distal femur, 2 plates (left and right) for the lateral proximal tibia, and 1 plate for the medial proximal tibia. The DePuy Synthes 3.5 mm Broad LCP & 4.5 mm Broad LCP Distal Humerus Plates are contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate has dynamic compression holes combined with locking holes which accept 3.5 & 4.5 mm cortex, 3.5 & 4.5 mm self-tapping cortex, 3.5 mm shaft, 3.5,4.0, & 5.0 mm locking, and 4.0 mm cancellous screws. The plates are available in various lengths. The DePuy Synthes Clavicle Hook Plate is an anatomically designed L-shaped plate featuring a distal joint bridging hook with a rounded end. The shaft of the plate contains either dynamic compression screw holes or LCP plate holes. The plates accept 3.5 mm cortex, 4.0 mm cancellous and 3.5 mm locking screws (LCP Clavicle Hook Plate only). The DePuy Synthes 3.5 / 4.5 mm LCP® Metaphyseal Plates are contourable to match the anatomy, have a limited contact design, and are tapered at the plate head. The 3.5 / 4.5 mm metaphyseal plates feature combination dynamic compression / locking screws holes (combi-holes). The plates in this system accept 3.5 / 4.5 mm cortex, 3.5, 4.0, & 5.0 mm locking, and 4.0 mm or 6.5 mm cancellous screws. The plate also has a 2.0 mm hole for preliminary fixation with k-wires. The DePuy Synthes 3.5 mm LCP Distal Humerus System consists of medial and posterolateral distal humerus plates of various lengths and 2.7 mm locking screws. The plates are pre-contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate features locking compression holes and conical locking holes which accept 2.4, 3.5, & 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium. The DePuy Synthes LCP Proximal Humerus Plates, long are pre-contoured to match the anatomy of the proximal humerus with a limited contact low profile design. The plate features locking holes and combination locking and compression holes which accept 2.7, 3.5, & 4.0 mm cortex screws, 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium. These plates will be offered as an addition to the DePuy Synthes Small Fragment LCP (formerly DCL) System. The DePuy Synthes LCP® Curved Plates have a slight curve to better match the anatomy of the bone. The plates have a limited contact profile design and includes combination dynamic compression/locking screw holes. The DePuy Synthes 3.5 mm Low Profile Reconstruction Plates consist of straight, curved, and J-shaped plates. The shape and profile of these plates are designed to minimize soft tissue irritation and minimize the need for intraoperative contouring. However, when intraoperative contouring is required for a precise fit with the bone, the plate design allows for simple and uniform bending. The DePuy Synthes 3.5mm Spring Plate is a variation of the DePuy Synthes one-third tubular plate with collar which utilizes two sharp spikes at the bottom surface and a pre-bent convex shape to aid in the reduction of small bone fragments while conforming to bony uneven surfaces. The plate incorporates a 1 - 10 hole design in lengths ranging from 19.5mm - 132mm and accepts either 3.5mm cortex or pelvic screws. In addition the plates are manufactured from Stainless Steel and Commercially Pure Titanium and provided STERILE and NON STERILE. The DePuy Synthes 3.5 mm LCP Hook Plate is a low-profile, precontoured bone fixation plate intended for the treatment of fractures, osteotomies, and non-unions in small bones. The plates feature a preformed dual hook on one end and are available in stainless steel and titanium. The DePuy Synthes 3.5 mm LCP Periarticular Proximal Humerus Plates are low-profile, precontoured bone fixation plates intended for the treatment of fractures of the humerus. The plates are offered sterile and non-sterile and are available in stainless steel and titanium. The DePuy Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications consist on.5 mm LCP plates, 4.5 rom Narrow LCP Plates, 4.5 mm Broad LCP plates and 4.5 mm Curved Broad LCP Plates for fracture fixation in adults and pediatric patients. These plates accept locking, cortex and cancellous screws. The DePuy Synthes 3.5mm Locking Attachment Plates are low-profile, pre-contoured plates which are intended to be used with existing Synthes to stabilize fractures. The plates are available in stainless steel and titanium. The DePuy Synthes Curved Narrow and Broad LCP Plates are available in stainless steel and titanium, and consist of limited-contact profile plates in 3.5 mm and 4.5mm narrow and broad sizes. The plates feature Dynamic Compression Plate (DCP) holes combined with locking screw holes. The 3.5mm plates accept 3.5mm cortex and locking screws and 4.0 mm cancellous screws, and the 4.5mm plates accept 4.5 mm cortex screws, 4.0mm and 5.0mm locking screws, 4.5 mm cannulated screws, 5.0 mm periprosthetic screws, and 6.5 mm cancellous screws. The DePuy Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System consists of plates of various lengths and variable angle screws that provide the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole. The system features medial and lateral plates that are pre-contoured to match the anatomy of the clavicle and a limited contact, low profile design. The plate with lateral extension features Variable Angle (VA) Locking holes and Dynamic Compression Plate (DCP) holes. The medial plate features Dynamic Compression Plate (DCP) holes combined with VA locking screw holes. The DePuy Synthes 3.5 mm LCP Clavicle Plate System consists of metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle. The DePuy Synthes Variable Angle LCP Elbow System contains plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. In its entirety, the following plate types are included in the system: - -Medial Distal Humerus Plate - -Lateral Distal Humerus Plate - -Olecranon Plate - -Proximal Olecranon Plate Extra-articular Proximal Ulna Plate The system accepts existing conical and locking screws as well as new metaphyseal screws, and allows for both dynamic compression and locking through Combi holes. The plates are universally designed for both left and right use and will be offered in both stainless steel and titanium. The DePuy Synthes Variable Angle LCP Elbow System contains posterolateral and medial plates intended to treat fractures of the distal humerus. The plates are used together in a two-plate, 90° construct and accept existing screws. New 2.7mm Metaphyseal Screws are also compatible with the System. The DePuy Synthes TOMOFIX Osteotomy System consists of five different titanium plate families with locking and combination locking/compression holes. This system features plates designed to provide stable fixation of osteotomies of the distal femur and proximal tibia. The DePuy Synthes TOMOFIX Medial Distal Femur Plates are part of the DePuy Synthes TOMOFIX Osteotomy System used for closed wedge femoral osteotomies. The subject plates are anatomically contoured to fit the medial distal femur, are available in right and left versions, as well as sterile and non-sterile. The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will be available in stainless steel and titanium. The head of the plate will remain the same as the existing 2.4mm VA-LCP Two-Column Volar Distal Radius Plate (K102694) and will therefore allow the use of the existing guide block for these plates. The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will come in 3 different lengths (7 shaft holes, 10 shaft holes and 13 shaft holes). To accommodate different patient anatomy, the plate with 7 shaft holes will be available with three different plate head widths (Standard, Narrow and Wide). The 10 shaft hole and the 13 shaft hole plate will only be released with the Standard plate head width and additionally they feature a curvature in the shaft. All plates will feature left- and right-specific designs and will be offered in sterile packed only. The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plates, Extra-Long are designed to accept existing 2.4mm Variable Angle Locking Screws, 2.4mm Cortex Screws, 2.4mm Locking Screws, 1.8mm VA Buttress Pins and 1.8mm Locking Buttress Pins in the plate head holes. In the plate shaft, existing 2.4mm Cortex Screws, 2.7mm Cortex Screws, 2.4mm Variable Angle Locking Screws, 2.7mm Variable Angle Locking Screws, 2.4mm Locking Screws, and 2.7mm Locking Screws can be inserted.
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    K Number
    K172975
    Device Name
    DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
    Manufacturer
    Synthes (USA) Products LLC/DePuy Orthopaedics Inc
    Date Cleared
    2018-06-21

    (267 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Synthes (USA) Products LLC/DePuy Orthopaedics Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DePuy Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants. The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates. 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 Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants. The Wire Mount is designed for use in dynamic compression screw holes that accept a 4.5 mm bone screw. The Wire Mount (and cerclage wire) can be used with a variety of plates that include, but are not limited to the following. Dynamic Hip Screw (DHS) Plates, Dynamic Condylar Screw (DCS) Plates, Condylar Buttress Plates, Hook Plates, 4.5 mm Narrow and Broad Dynamic Compression Plates (DCP), 90° Child and Adolescent Osteotomy Plates, 110-130° Adult Osteotomy Plates, and 95° Condylar and 130° Angle Blade Plates (both including small stature plates). The DePuy Synthes Cerclage Positioning Pins are intended for use with cerclage monofilament wire and multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants. Cerclage Positioning Pins are designed for use with plates having locking compression or dynamic compression screw holes that accept a 3.5 mm or 4.5 mm bone screws. The Cerclage Positioning Pin (and cerclage wire or cable) can be used with a variety of Synthes plates.
    Device Description
    The DePuy Synthes 5.0 mm and 7.3 mm Crimp Positioning Pins are designed to fit into the screw holes of existing DePuy Synthes fixation plates for the purpose of providing a guide for Cerclage cable positioning as well as a crimping point for Cerclage cable tension fixation. The Crimp Positioning pins are available in versions composed of implant quality stainless steel and titanium. The VA 5.0 Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0mm variable angle bone screws. Positioning or cerclage pins are intended for use with cerclage monofilament wire or 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 Wire Mount is intended for use with cerclage wire to augment fracture stabilization with plates when use of screws is contraindicated, as in the presence of intramedullary implants. The design is a "T" post with a hole perpendicular to the post axis, and a small triangular ridge on the bottom. Placing the post through the dynamic compression screw hole, inserting from the bone side of the plate, creates a stable structure for cerclage wire fixation. The cerclage wire is passed around the bone, through the wire mount hole above the outer surface of the plate, and then twisted with the opposite wire end. The design of the cerclage positioning pin is an oval body with a hole running perpendicular to the long axis (for use in compression holes), and has a stud protruding from the bottom. By placing the post through the top of the dynamic compression screw hole into a pre-drilled hole in cortical bone a stable structure is created for cerclage wire or cable fixation. The wire or cable is passed around the bone, through the Cerclage Positioning Pin hole above the outer plate surface, and then the wire is twisted or cable is crimped for final securement.
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    K Number
    K160553
    Device Name
    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
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
    Date Cleared
    2017-06-30

    (487 days)

    Product Code
    HRS, HSB, HTY, HWC, JDS, KTT, KTW, LXT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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 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 lones, 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, 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, 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 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, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System. The DePuy Synthes Stainless Steel Modular Hand System is 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 extraarticular 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, cervicotrochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture 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. The DePuy Synthes Tibial Nail System Ex is intended to stabilize fractures of the proximal and the tibial shaft; open and closed tibial shaft fractures; certain pre- 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 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. 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 fractures, such as radial neck fractures and is intended for fixation of small 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 wrist; theumatoid 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. 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 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, nonunions, replantations, and fusions of 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, 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. 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 fractures, such as radial neck fractures and is intended for fixation of small 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. 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 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, distal tibia, fibula, particularly in osteopenic bone for adult patients. These plates are also indicated for fracture fixation of diaphyseal 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 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 intraand 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 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 extraarticular 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, replantations and fusions of 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 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 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 exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush 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 small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures extiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush 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: intraarticular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush 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 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: 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 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 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, 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 bone fragments, including the foot, ankle, and hand 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 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, nonunions, replantations, and fusions of 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 wedial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, tibial osteotomies and osteopenic bone. The DePuy Synthes MultiLoc Humeral Nailing System is indicated for fractures of the proximal humerus, including 2part surgical neck fractures, 3-part fractures, and 4-part 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, mal unions, and replantations of bones and bone fragments of the diaphyseal regions of the distal tibia, · Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fragments of the distal tibia, and · Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, non unions, 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, and replantations of bones and bone fragments of the diaphyseal regions of the distal tibia. · Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, mal unions, and replantations of bones and bone fragments of the diaphyseal 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, mal unions, 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 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 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, 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 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, osteotomies, non-unions, and malunions of 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 temoral neck fractures; intercondylar femur fractures; Sl 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 intraarticular and extra-articular fractures, avulsions, non-unions, 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 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 intraarticular 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 pediations, 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 implants, for implantation through the skin, and as traction pins so that traction may be applied to the skeletal system.
    Device Description
    The DePuy Synthes 4.0 mm and 5.0 mm Locking Screws are an added option to the 3.9 mm and 4.9 mm Locking Bolts. The locking screws are used in conjunction with Synthes intramedullary nails to stabilize fractures of the tibia, humerus and femur. The Locking Screws are designed with a Synthes truncated cortex screw thread profile and a double lead thread to allow a progression through bone similar to the locking bolt. The tip of the 4.0 mm and 5.0 mm Locking Screws is trocar, selftapping and the core diameters are 3.3 mm and 4.3 mm, respectively. The locking screws are available in lengths ranging from 18 - 80 mm (4.0 mm) and 26 - 100 mm (5.0 mm). The DePuy Synthes Wrist Fusion Plate (WFP) feature a limited-contact profile and dynamic compression unit (DCU) screw holes which accept 3.5 mm cortex and 2.7 mm cortex screws. The plates are available in three designs (standard, short, and straight) to accommodate the anatomic needs of the patient. The standard plate accommodates average-sized individuals; the short bend plate fits small-statured individuals or patients with previous proximal row carpectomy; and the straight plate may be contoured to unusual anatomy or the severely deformed wrist joint. The straight plate also accommodates patients with severe bone loss requiring a corticocancellous strut from the iliac crest. The standard plate and short bend plates have a built-in fusion angle of 10° dorsiflexion, and are 112 mm in length. These plates feature a pre-contoured carpal bend. The straight plate is 110 mm in length without the carpal bend and built-in fusion angle. The DePuy Synthes Large Fragment DCL system consists of limited-contact profile plates in broad and narrow sizes, which include combination dynamic compression/locking screw holes. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, and 5.0 mm locking screws. This device is manufactured in either stainless steel or titanium. The DePuy Synthes Small Fragment DCL system consists of limited-contact profile plates in straight, reconstruction, Oblique T- and Small T- plates of various sizes and 3.5 mm locking screws. The plates in this system also accept 2.7 mm and 3.5 mm cortex, and 4.0 mm cancellous screws. The plates feature a combination dynamic compression/locking screw hole. The system is available in either stainless steel or titanium. The DePuy Synthes Modular Foot System is a series of plates and screws with plates of varying lengths and thicknesses and configurations including T-, LC-DCP, Condylar, and Cuboid Plates. These plates are attached to bone via 1.8 mm buttress pins and 2.0 mm and 2.4 mm selftapping cortex screws. The DePuy Synthes Locking Compression Plate (LCP) System - T Plate is a buttress plate and screw system. The primary feature of the plate is round holes combined with locking screw holes. The locking screws form a locked, fixed angle construct with the plate, while the standard screws facilitate reduction and create compression between the plate and bone. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0 mm locking screws. The DePuy Synthes One-Third Tubular DCL Plate line extension is a threaded version of the currently marketed Synthes Third Tubular Plate. The threaded plates will accept locking screws and therefore can be included as part of the The DePuy Synthes Small Fragment DCL System. The plates have the same intended use as other plates in the system and there is no change in safety or efficacy. The DePuy Synthes Stainless Steel Modular Hand System is a series of plates and screws of varying lengths and thic1mess, and configurations including straight, T-, Y-, and extended Hplates. These plates are attached to bone via 1.8 mm buttress pins and 1.0 mm, 1.5 mm, 2.0 mm, and 2.4 mm self-tapping cortex screws. The DePuy Synthes Ti-15Mo Locking Distal Radius Plating System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal end of the radius. The DePuy SynthesLCP Proximal Femur Hook Plates are contoured to match the anatomy of the proximal femur with a limited contact low profile design. The plate has dynamic compression holes combined with conical shaped threaded screw holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or 5.0 mm locking screws, 5.0 mm cannulated screws, and 7.3 mm cannulated locking & cannulated conical screws. The plates are available in a various lengths The DePuy Synthes Titanium Cannulated Humeral Nail System consists of cannulated titanium intramedullary rods, and end caps in a variety of sizes designed for treatment of various humeral fractures. A 2.0 mm guide wire is used with the system. The DePuy Synthes Tibial Nail System Ex is composed of cannulated tibial nails, 5.0 mm dual core locking screws and end caps. The 5.0 mm dual core locking screws, end caps, and Synthes commercially available locking screws and locking bolts are used to secure the nail in the bone, preventing rotation and axial compression. The DePuy Synthes LCP® Curved Plates have a slight curve to better match the anatomy of the bone. The plates have a limited contact profile design and includes combination dynamic compression/locking screw holes. The DePuy Synthes EIN system consists of flexible intramedullary fixation devices that vary in diameters and lengths, which can be cut to size intraoperatively. The EIN has a curved tapered tip to facilitate insertion and manipulation. The EIN is manufactured from Titanium Alloy. The DePuy Synthes LCP Wrist Fusion Plates are pre-contoured with a limited contact design utilizing a short bend with a 3.3 mm thickness and a width of 11 mm. The plate uses a total of 10 combination holes which utilizes 2.7 mm and 3.5 mm cortex and locking screws. The plates are available in Titanium and Stainless Steel. The DePuy Synthes Spherical Washers are round or oval in design with a slotted center hole which allows for screw angulation up to 70 degrees. They are used with 4.5 - 7.3 mm diameter screws and manufactured from Stainless Steel and Titanium. The DePuy Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the Synthes Elastic Intramedullary Nail (EIN) System. The Titanium Elastic Nail End Cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation. The threads are self-tapping with reverse cutting flutes to facilitate end cap removal. The back end of the cap is blunt to minimize soft tissue irritation. The DePuy Synthes Modular Mini Fragment LCP System includes 2.0 mm, 2.4 mm, and 2.7 mm size implants. The system incorporates a series of locking compression plates and screws of varying lengths, thicknesses, and configurations including straight, condylar, T-, Y-, adaption plates. These plates are attached to bone via 2.0 mm, and 2.7 mm cortex and locking screws. The DePuy Synthes LCP Dia-Meta Volar Distal Radius Plates provide stable fixation for radius fractures. The plates have threaded locking holes in the head of the plate that accept 2.4 mm locking screws, and dynamic compression holes combined with locking holes in the shaft of the plate which accept 3.5 mm cortex, 3.5 mm locking, or 4.0 mm cancellous screws. The plates are available in various lengths and are available in right and left versions to accommodate varying patient anatomy. The plates are manufactured in either titanium or stainless steel. The DePuy Synthes VA-LCP Distal Radius System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal portion of the radius. The DePuy Synthes VA-LCP Distal Radius System enhances fragment-specific fracture fixation by providing the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole. The DePuy Synthes Stainless Steel Elastic Intramedullary Nail System consists of intramedullary fixation devices that vary in diameters and lengths, which can be cut to size intra-operatively. The nails have a curved tip to facilitate insertion and manipUlation. The end cap is inserted over the external portion ofthe nail and threaded into the cancellous bone. The DePuy Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the Synthes Elastic Intramedullary Nail (EIN) System. The end cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation. The DePuy Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications consist of 3.5 mm LCP plates, 4.5 mm Narrow LCP Plates, 4.5 mm Broad LCP plates and 4.5 mm Curved Broad LCP Plates for fracture fixation in adults and pediatric patients. These plates accept locking, cortex and cancellous screws. The DePuy Synthes 2.4 mm Variable Angle LCP (VA-LCP) Two-Column Volar Distal Radius Plate is a machined metal plate that is designed for fixation of various fracture modes of the distal portion of the radius. The 2.4 mm VA-LCP Two-Column Volar Distal Radius plate allows fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. The DePuy Synthes variable angle locking technology enhances plate-screw construct stability. The plates are manufactured in either titanium or stainless steel. The DePuy Synthes 1.5 mm Mini Fragment LCP System consists of lowprofile plates of various shapes as well as locking and cortex screws which are intended to treat small bones and small fragments. The plates and screws of the 1.5 mm Mini Fragment LCP System are available in stainless steel and titanium. The DePuy Synthes 2.4 mm LCP Volar Column Distal Radius Plates are part of the Synthes Locking Distal Radius System which is a system consisting of metallic bone fixation plates designed to treat fractures and osteotomies of the distal radius. The DePuy Synthes Locking Hand plates consist of 2.0 mm LCP Distal Ulna Plates and 1.5 mm/2.0 mm and 2.0 mm Rotation Correction Plates which offer both stainless steel and titanium plating options merging locking screw technology with conventional techniques. Locking screws provide the ability to create a fixed angle construct while utilizing familiar AO plating techniques. A fixed-angle construct provides improved fixation in osteopenic bone or multi fragment fractures where traditional screw purchase is compromised. The DePuy Synthes 2.4 mm V A-LCP Two-Column Narrow Volar Distal Radius Plates are metallic plates intended for treatment of various fracture modes of the distal radius. The plates incorporate variableangle locking hole technology and are available in versions composed of stainless steel and titanium. The DePuy Synthes 2.4 / 2.7 mm Variable Angle LCP Forefoot / Midfoot System consists of anatomic and procedure specific plates, including 1st MTP Fusion, TMT Fusion, Opening Wedge Osteotomy, X and Straight Fusion, Navicular, Cuboid, and Mesh Plates, with variable angle locking screws and cortex screws to aid in reconstructive foot surgery. The system components are offered in versions composed of implant grade stainless steel and titanium alloy. The DePuy Synthes 2.4 mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. The dorsal plate has a pre-contoured design to fit along the dorsal radial column of the distal radius. These plates incorporated variable angle locking technology. There are a variety of plate types and they are available in 316L Stainless Steel and CP4 Titanium. The plates are offered in 5 basic shapes: 2-hole L-plate, a 3-hole L-plate, straight (radial column) plates, oblique plates and T plates. The L-plates, T -plates, and oblique plates come in 3- and 5-hole lengths. The straight (radial column) plates come in 5- and 6- hole lengths. The 2-Hole L-plate, a 3-hole L-plate, and oblique plates are also offered in left and right-angled configurations The DePuy Synthes MultiLoc Proximal Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the proximal humerus for the fixation of fractures. The system features intramedullary nail devices, as well as 4.5 mm bone screw and end cap accessories. The nails are cannulated, are offered in 8.0 mm diameters, and 160 mm in overall length. The nail, screw, and end cap devices are composed of titanium alloy. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5 mm MultiLoc proximal locking screws. The 4.5 mm MultiLoc Screws which are used to facilitate the proximal locking of the nail construct can be interlocked with existing Synthes 3.5 mm Locking Screws to enhance the stability of the construct. The DePuy Synthes 2.4 mm VA-LCP Intercarpal Fusion System features low profile circular plates. The plates are available in two sizes: ø15 mm (6 holes) and ø17 mm (7 holes). The plates each feature variable angle locking technology. The plates also feature K-wire holes for positioning and temporary fixation. The DePuy Synthes 2.4 mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. These plates incorporate variable angle locking technology. The Variable Angle LCP Volar Rim Distal Radius Plates are designed as low profile plates, designed to minimize soft tissue irritation by featuring a low contoured plate profile with countersunk screws, rounded edges, and polished surfaces. The plates feature both variable angle locking screw holes in the head and shaft and elongated variable angle combination holes along the shaft only. The plates are offered in 6and 7-hole head configurations each with two additional contourable wing tabs with screws holes to provide even greater variability in screw placement for additional fracture reduction. The DePuy Synthes 3.5 mm Low Profile Cortical Screws are self-tapping, have either a stardrive or hex drive recess, are manufactured from stainless steel and titanium and offered both sterile and non sterile. The self-tapping screws are available in lengths ranging from 10 mm – 110 mm and may be used independently or with any Synthes plate which accepts Synthes 3.5 mm cortical screws. The low profile screw head is designed to minimize hardware prominence and the resultant potential for soft tissue irritation. The DePuy Synthes system is a collection of plates used to treat fractures and osteotomies of the femur in infants, children, adolescents, and small statured adults. The complete system includes the following: - 3.5mm and 5.0 mm plates with a 90° angle . - 2.7mm, 3.5mm and 5.0 mm plates with a 100° angle - . 2.7mm, 3.5mm and 5.0 mm plates with a 110° angle - . 3.5mm and 5.0 mm plates with a 120° angle - . 2.7mm, 3.5mm and 5.0 mm plates with a 130° angle - 3.5mm and 5.0 mm plates with a 140° angle - . 3.5mm and 5.0 mm plates with a 150° angle The system accepts existing cortical and locking screws, and features allows for both dynamic compression and locking through Combi holes. The plates are universally designed for both left and right use. The DePuy Synthes Cortical Screws have self-tapping features, stardrive, or cruciform head recesses, and are manufactured from stainless steel, commercially pure titanium, and/or titanium alloy. Cortex screws are offered both sterile and non sterile and are available in various lengths. Screws may be used independently or with any Synthes plate which accepts 1.0 mm, 1.3 mm, 2.0 mm, 2.4 mm, 2.7 mm, 4.0 mm, and 4.5 mm cortex screws. The subject screws, when used in pediatric applications, may be used independently or with compatible Synthes plates which are also indicated for pediatric populations. The DePuy Synthes 2.7 mm LCP Ulna Osteotomy System consists of two plates, 6-hole and 8hole which will be available in titanium alloy and stainless steel, to be offered sterile and nonsterile. This system also includes instrumentation which supports transverse and oblique osteotomy cuts as well as plate placement and fixation. The DePuy Synthes 3.5 mm VA-LCP Proximal Tibia Plate System consists of pre-contoured bone fixation plates intended for the treatment of fractures of the proximal tibia. Variable angle screws can be angled up to 15 degrees from the normal trajectory prior to locking the screw to the plate. Percutaneous instrumentation will allow the variable angle plates and screws to be applied through minimally invasive techniques. The DePuy Synthes MultiLoc Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the humerus for fracture fixation. The system features intramedullary nail devices, as wen as bone screws and end cap accessories. The nails are cannulated, offered in 7.0 mm, 8.5 mm, and 10 mm diameters, and are available in 180 mm-315 mm in overall length. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5mm MultiLoc locking screws. Cleared 4.5 mm MultiLoc Screws, used to facilitate the proximal locking ofthe nail construct, can be interlocked with cleared Synthes 3.5 mm Locking Screws to enhance the stability of the construct. The DePuy Synthes Variable Angle LCP Ankle Trauma System contains plates that are intended to treat fractures of the ankle, and includes multiple plate types to accommodate different fracture patterns and patient anatomy. Two screw configurations are included in the Synthes Variable Angle LCP Ankle Trauma System; 2.7 mm metaphyseal screws and 3.5 mm VA Locking Screws. Specifically, the following plates and screws are included in the Synthes Variable Angle LCP Ankle Trauma System: - Medial and Anteromedial Distal Tibia Plates . - Distal Tibia T Plates and Distal Tibia L Plates . - Lateral Distal Fibula plate - 2.7mm Metaphyseal Screws - . 3.5mm VA Locking Screws All of the plates will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. All of the plate configurations (with the exception of the Distal Tibia T plate, which is symmetrical), will be offered in left and right designs. The system accepts existing cortical and locking screws (i.e. K000684 and K043185) as well as 3.5 mm VA Locking Screws and 2.7 mm Metaphyseal Screws, and allows for both dynamic compression and locking through Combi holes. The DePuy Synthes Anterolateral Distal Tibia Plates are intended to treat fractures of the distal tibia. The Anterolateral Distal Tibia Plates and 3.5 mm VA Locking Screws are offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. The Anterolateral Distal Tibia Plates will be offered in left and right configurations. The system accepts existing cortical screws, locking screws, dynamic locking screws, and metaphyseal screws as well as 3.5 mm VA Locking Screws, and allows for both dynamic compression and locking through Combi holes. The DePuy Synthes 2.7 mm and 3.5 mm Variable Angle LCP Midfoot/Hindfoot System is a collection of plates used for fixation of fractures of the foot and, ankle 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. The complete system includes the following plate types: - 2.4mm/2.7mm Variable Angle Locking Talus Plate - 2.7mm Variable Angle Locking Calcaneal Plate - 2.7mm Variable Angle Locking Anterolateral Calcaneal Plate - 3.5mm Variable Angle Locking Compression Medial Column Fusion Plate ● The system accepts various screw fixation options such as existing cortical, locking, variable angle locking, low profile, cannulated locking, cannulated conical and metaphyseal screws. The plates are low profile in design and offered in variations of Stainless Steel, Commercially Pure Titanium-Grade 4, and Titanium Alloy (TAN). When used in conjunction with a plate system, the system mdications apply to the entire construct. including the screws . The DePuy Synthes Cortex, Cannulated, and Headless Compression Screws are metallic bone screws manufactured from Stainless Steel (ASTM F138), Commercially Pure Titanium (ASTM F67), and/or Titanium Alloy (ASTM F1295). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions 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 Cannulated and Headless Compression screws are cannulated for use with guidewires for precise placement in bone with the exception of the 1.5 mm Headless Compression Screw, which is a solid screw and therefore does not allow for instrumentation with a guide wire. The Headless Compression Screws feature threaded heads that allow for purchase in the near cortex of bone during and after implantation, potentially reducing complications associated with countersinking of traditional cortex or cannulated screws. The DePuy Synthes 4.5 mm VA LCP Curved Condylar Plate System consists of anatomicallycontoured, stainless steel and titanium plates and screws featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur and system specific instrumentation. The current 510(k) introduces OPTILINK™ Technology stainless steel screws, positioning pins for cerclage cable, and system specific instrumentation as a line extension to the currently cleared Synthes 4.5 mm VA LCP Curved Condylar Plate System. The DePuy Synthes Angled Blade Plates are manufactured from 316L stainless steel. The plates are of various angles and offsets to accomodate specific surgical application, and are attached with stainless steel screws. The DePuy Synthes URHN is intended to stabilize fractures of the humerus. It is specifically indicated for acute humeral shaft fractures, pathologic or impending pathologic fractures of the humeral shaft, and non- and mal unions 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 consists of volar and dorsal plates, 2.4 mm cortex screws, and 1.8 mm threaded-head buttress pins. The volar plate is T-shaped, with the head 18° from perpendicular to the shaft; it is precontoured with a 20° bend near the head and has six threaded screw holes that are angled 10° proximally. The dorsal plate is shaped like the Greek letter Pi, with two proximal legs (shaft) and one distal arm (head); it is precontoured, and has six internally threaded screw holes in the head. The heads of both plates have a 30° ramp added to the proximal (volar plate) and distal (dorsal plate) sides. The shafts of both plates have a 45° chamfer and compression screw holes. Both plates are available in right and left versions; accept cortex screws (2.7 mm and 2.4 mm) and 1.8 mm threaded-head buttress pins; and can be cut to size. The DePuy Synthes LCPs are designed to address complex fractures of the calcaneus and are applied to the lateral side. The plate has 15 threaded screw holes, which accept 2.7 mm and 3.5 mm cortex screws, as well as 3.0 mm locking screws. The plates are available for right and left placements. The DePuy Synthes Spiral Blade for Humerus Nail is used in conjunction with Synthes Unreamed Humeral Nail to stabilize fractures of the humerus. The SBHN is available in lengths ranging from 34 mm to 54 mm in 2 mm increments. A Locking End Cap is used to lock the Spiral Blade in place. The Locking End Cap has a 5 mm extension. The DePuy Synthes K-Wires are used 1) with Synthes External Fixators and Lengthening Apparatus; 2) as an intraoperative reduction/stabilization tool; 3) for percutaneous fixation of fractures; and 4) as a guide for screws and drill bits. The K-wires are straight wires with a trocar tip on one or both ends and are available in various diameters and lengths. The DePuy Synthes Guide Wires are straight wires with a point on one or both ends and are available in various diameters and lengths. They are used to reduce and stabilize bone fractures. The wires can also be used as a guide for cannulated implants.
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