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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 4.5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar and extra-atticular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

DePuy Synthes 3.5mm Quadrilateral Surface Plates for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates.

The DePuy Synthes 2.7 mm / 3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.

DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of the proximal, distal, and metaphyseal areas of the tibia.

DePuy Synthes TornoFiX Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

The DePuy Synthes LCP Distal Tibia T Plates are indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone.

The DePuy Synthes 2.4/2.7 mm Locking Foot Module is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, including the foot and ankle, particularly in osteopenic bone.

DePuy Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprostheic fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.

DePuy Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.

The DePuy Synthes LCP Proximal Tibia System is intended for treatment of nonunions, osteopenic bone, tibial osteotornies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

The DePuy Synthes 3.5 / 4.5mm LCP Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia shaft, as well as opening and closing wedge tibial osteotomnies.

The DePuy Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, reconstructive procedures and replantations of small bones including the foot and ankle.

The DePuy Synthes LCP Dynamic Helical Hip System is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

The DePuy Synthes LCP Proximal Femur Hook Plates are intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of the proximal end of the femur combined with ispsilateral shaft fractures of the proximal femur and osteotomies of the proximal femur.

DePuy Synthes 3.5 Low Profile Pelvic Reconstruction Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.

DePuy Synthes LCP Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of the proximal end of the femur combined with ispsilateral shaft fractures of the proximal femur and osteotomies of the proximal femur.

DePuy Synthes 3.5mm Titanium LCP Proximal Tibia Plate is intended for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The DePuy Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar, combination of lateral wedge and depression, and fractures with associated shaft fracture.

The DePuy Synthes Locking Compression Plate (LCP) System is intended for fixation of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone. The DePuy Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the DePuy Synthes Small Fragment LCP System.

The DePuy Synthes LCP Proximal Tibia Plate is intended for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The DePuy Synthes Modular Foot System - 2.7 mm Module is intended for fractures, osteotomies, fusions and replantations of small bones including the foot, ankle, and hand.

DePuy Synthes Medial Distal Tibia Plates are indicated for the fixation of the distal tibia including, but not limited to, ankle fractures, periarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

DePuy Synthes Modular Foot System is intended for fractures, and replantations of small bones including the foot, ankle, and hand.

The DePuy Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

DePuy Synthes Locking Calcaneal Plates are indicated for fractures of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures.

The DePuy Synthes Proximal Tibia Plating System is intended for non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

DePuy Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

DePuy Synthes Titanium Alloy High Tibial Osteotomy (HTO) System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component. It utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation.

The DePuy Synthes DHS is indicated for the following fractures of the proximal femur: Intertrochanteric fractures, Subtrochanteric fractures, Basilar neck fractures. The DHS is indicated for stable fractures, and unstable fractures in which a stable medial buttress can be reconstructed.

The DePuy Synthes Modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

The DePuy Synthes 4.5mm 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 4.5mm VA LCP Curved Condylar Plate System.

DePuy Synthes 3.5mm Quadrilateral Surface Plates consist of metallic plates pre-shaped to fit the quadrilateral surface of the pelvis. The plates are provided in shodt, standard, and long versions.

DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured to match the anatomy of the distal fibula and diaphyseal region. The plates feature a low-profile design and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mm shaft, 3.5 mm locking screws, and 4.0 mm cancellous screws. The plates locking holes accept 2.4 mm, 2.7 mm locking screws along with 2.4 mm and 2.7 mm self-tapping cortex screws. The plates are available in stainless steel and titanium, as well as a variety of lengths.

The DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are pre-contoured bone fixation plates intended for the treatment of fractures of the tibia. The plates are offered sterile and non-sterile and are available in stainless steel and titanium.

The DePuy Synthes TomnoFiX Medial Distal Femur Plates are part of the Synthes TomnoFiX Osteotomny System which is a system consisting of titanium plates with locking and combination holes designed to provide stable fixation of osteotornies close to the knee. The TomoFiX Medial Distal Femur Plates consist of titanium plates anatomically contoured to fit the medial distal femur. The plates are available in right and left versions and feature locking holes in the head and combination locking/dynamic compression holes in the shaft.

DePuy Synthes 3.5 mm LCP Distal Tibia T Plates are contoured to match the anatomy of the distal tibia. The plates have both combination and locking screw holes which accept various Synthes screws. They are available in stainless steel and titanium, in a variety of lengths.

DePuy Synthes 2.4/2.7 mm Locking Foot Module consists of locking foot plates of various shapes and sizes to accommodate patient anatomy and orthopedic conditions in the foot and ankle. The plates are attached to bone via 2.4 and 2.7 mm cortex and locking screws.

DePuy Synthes LCP Distal Femur Plates are part of the Synthes Locking Compression Plate (LCP) System. The plates have a low profile design, are available in left and right versions with Dynamic Compression Plate (DCP) holes combined with locking screw holes in the shaft of the plate and threaded screw holes in the head of the plates will be offered in stainless steel and titanium and will be available in sterile and non-sterile versions.

DePuy Synthes LCP Ankle Arthrodesis Plates are minimally contoured metal plates that utilize locking screw technology to promote fusion or "arthrodesis" of the ankle. The plates will be offered in stainless steel and commercially pure titanium and will be available in sterile and non-sterile versions.

The DePuy Synthes LCP Proximal Tibia System are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. These are plates designed for either the right or left tibia in a variety of shaft lengths. The plates have overall lengths ranging from 298 nun to 370 mm and shaft holes ranging from 16 to 20 holes.

The DePuy Synthes (USA) 3.5 / 4.5 mm LCP® Medial Proximal Tibia Plates are contoured to match the anatomy of the medial proximal tibia with a limited contact low profile design. The plates are designed for either the right or left medial proximal tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plate head exhibits 2.0 mm holes for preliminary fixation with k-wires, or meniscal repair with sutures.

DePuy Synthes LCP Modular Foot Plates consist of locking cuboid, navicular and talus plates used to treat small bone fractures. The plates are attached to bone via 2.4 and 2.7 mm cortex and locking screws.

DePuy Synthes LCP Dynamic Helical Hip System is a plate and screw system that consists of a straight plate with an angled barrel that accepts a helical blade. T1he plates have a grooved undersurface, contain combination locking and dynamic compression holes and are available in various barrel angles and plate lengths. The sideplate combination holes accept 5.0 mim locking screws and 4.5 mim cortex screws.

The DePuy Synthes LCP 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, 5.0mm cannulated screws, and 7.3 mm cannulated locking & cannulated conical screws. The plates are available in a various lengths

DePuy Synthes 3.5 mm Low Profile Pelvic Reconstruction Plates consist of curved plates and straight plates that are contourable in three planes. The plates have a smooth, rounded profile. Plate holes are slightly oval, allowing 30 degrees of angulation in all directions. The 3.5 mm Low Profile Reconstruction Plate accepts Synthes 3.5 mm Cortex Screws and Synthes 3.5 mm Pelvic Screws.

The DePuy Synthes LCP Proximal Femur Plate 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, and 7.3 mm cannulated locking & cannulated conical screws. The plates and screws are available in a various lengths.

The DePuy Synthes 3.5mm Titanium LCPTM Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. The plates are designed for either the right or left tibia and are available in a variety of lengths. The plates are svailable in a variety of lengths. The proximal portion of the plate head accepts 3.5mm titanium locking screws, the distal portion of the plate accepts 3.5 mm titanium locking screws, 3.5 mm titanium cortex screws, or 4.0 mm titanium sancellous bone screws.

The DePuy Synthes Titanium 4.5mm LCP Proximal Tibia Plating System consists of 4.5 mm Titanium LCP Proximal Tibia Plates, 5.0 mm Titanium Cannulated Locking and Conical screws, and 4.0 mm and 5.0 mm Titanium Solid Locking screws. The Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. These are plates designed for either the right or left tibia in a variety of shaft lengths. The plate head has threaded screw holes and 2.0 mm holes for preliminary fixation with kwires, or meniscal repair with sutures. The plate shaft has combination screw holes (dynamic compression and locking screw holes), that accept 4.5 mm cortex, 6.5 mm cancellous, 5.0 mm cannulated locking, 5.0 mm conical, and 4.0 mm & 5.0 mm locking screws. A titanium screw nut is also utilized with this system

The DePuy Synthes Locking Compression Plate (LCP) System are machined metallic plates that offer screw to plate locking designed for various fracture modes of the distal end of the tibia and other small bones.

The DePuy Synthes LCP Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. There are plates designed for either the right or left tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plates are available in a variety of lengths. The locking screw holes accept both cannulated locking and conical screws. Two proximal round holes accept cortex screws, cancellous screws, or cannulated screws. The distal portion of the plate has combination dynamic compression locking screw holes that allow the option of using locking screws, cortex screws, or cannulated screws.

The DePuy Synthes Modular Foot System - 2.7 mm Module is a series of plates having various lengths, thickness, and configurations including L-, T-, HindiMidfoot, Calcaneal Reconstruction, Quarter Tubular, LC-DCP, and MTP Fusion Plates. These plates are attached to bone via 2.7 mm selftapping cortex screws.

DePuy Synthes Medial Distal Tibia Plates are available in two sizes: 3.5 mm and 4.5 mm. They are pre-contoured to fit the distal tibia anatomy. The plates feature a limited contact - dynamic compression plate design and are available (LC-DCP) in right and left versions. The end of the plate includes a hole for a suture, if necessary. The plates accept 3.5 mm, 4.0 mm, 4.5 min cortex screws, and 4.0 min cancellous screws.

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.

DePuy Synthes (USA) 3.5/4.5 mm LCP Medial Proximal Tibia Plates is a plate and screw system. The primary feature of the plate and screw system is that the locking screws engage with the head and shaft of the plate to form a locked, fixed angle construct. The system features limitedcontact profile, dynamic compression unit (DCU) and locking screw holes.

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 2.0 mm thick, 69 mm and 76 mm in length, and are available for right and left placements.

The DePuy Synthes Proximal Tibia Plating System consists of 3.5 mm and 4.5 mm Plates and a 3.5/4.5 mm Washer. The plates are anatomically contoured; feature a low profile, limited contact design, and are available in right and left versions. The heads of the plates include holes for K-wires or sutures, if necessary. The 3.5 mm Plates are used with 3.5 mm cortex, 4.0 mm cancellous, and 4.5 mm cannulated screws. The 4.5 mm Plates are used with 4.5 mm cortex, 6.5 mm cancellous, 7.0 mm and 7.3 mm cannulated screws. When used with the 3.5/4.5 washer, the 4.5 mm Plates can also be used with all of the screws that fit the 3.5 plates; the washer prevents the screw head from pulling through the plate holes. This device system is manufactured from stainless steel.

The DePuy Synthes DHSIDCS One-Step Lag Screws have a 12.7 mm or a 14.0 mm thread diameter and are available in lengths ranging from 50 mm to 145 mm. The DHSIDCS One Step Lag Screws feature an internal broach drive mechanism. The DHSIDCS One Step Lag Screws are manufactured from stainless steel.

DePuy Synthes Titanium Alloy HTO System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component. It utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation.

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The plate has six holes in the shaft and one hole beside the blade. The blades are set at a 90° either to the left or right of a coaxial plate hole. All plates can be cut to the desired length with plate cutting forceps.

I am sorry but this document does not contain the information requested. This document is a 510(k) premarket notification for several DePuy Synthes devices, primarily bone fixation plates that are being updated to include "MR Conditional" information in their labeling.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes used for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Information about the training set, its sample size, or how its ground truth was established.

Instead, the document focuses on demonstrating substantial equivalence for the listed devices by showing that the addition of MR Conditional information does not change their intended use or technological characteristics. This is mainly supported by non-clinical testing in the MR environment to assess:

• Magnetically induced displacement force (ASTM F2052-14)
• Torque (ASTM F2213-06)
• Radio frequency (RF) heating (ASTM F2182-11a)
• Image artifacts (ASTM F2119-07)

The document consistently states: "The non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy." This indicates that the devices meet safety criteria for MR compatibility.

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