DePuy Synthes Plates and Screws Portfolio

• K Number: K190750
• Device Name: DePuy Synthes Plates and Screws Portfolio
• Manufacturer: DePuy Synthes
• Date Cleared: 2019-06-21 ( 88 days)
• Product Code: HRS JDO JDP KTT KTW LXT
• Regulation Number: 888.3030

Intended Use

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.

Device Description

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. Not Found 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.

Predicate Devices

K162124, K093928, K083213, K082624, K081353, K080522, K071264, K062564, K061940, K052390, K050646, K050110, K033556, K032032, K031573, K030858, K030597, K023802, K013248, K011978, K010321, K001945, K001941, K000066, K991407, K983787, K964259, K963325, K791619, K063049

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes various bone plates and screw systems for fracture fixation and reconstruction. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The performance studies focus on the physical properties and MR compatibility of the devices.

Therapeutic

Yes.
The device is intended for "fixation of fractures" and "treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis," which are therapeutic applications.

Diagnostic

No

The provided text describes various orthopedic plates and screw systems. Their intended use is for the fixation of fractures, nonunions, replantations, fusions, and osteotomies of bones. These are therapeutic interventions, not diagnostic procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of metallic plates, screws, and instrumentation, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, these devices are not In Vitro Diagnostics (IVDs).

Here's why:

• Intended Use/Indications for Use: The intended use of all the listed devices is for the fixation of fractures, nonunions, replantations, fusions, osteotomies, and correction of deformities in various bones (hand, wrist, foot, ankle, femur, tibia, pelvis, etc.). This is a surgical intervention directly on the patient's body.
• Device Description: The descriptions detail metallic plates, screws, and systems designed to be implanted into bone. These are implantable medical devices.
• Lack of IVD Characteristics: An In Vitro Diagnostic device is intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any interaction with human specimens or diagnostic testing.
• Anatomical Site: The anatomical sites listed are all parts of the human musculoskeletal system where these devices are surgically implanted.
• Intended User/Care Setting: The intended use implies a surgical setting and likely involves trained medical professionals performing surgical procedures.

In summary, these devices are designed for surgical implantation to stabilize and fix bones, which is a therapeutic intervention, not an in vitro diagnostic process.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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, 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 and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

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

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

Product codes (comma separated list FDA assigned to the subject device)

HRS, KTT, KTW, LXT, JDO, JDP

Device Description

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.

Not Found.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

distal femur, hand, wrist, foot, ankle, pelvis, acetabulum, distal fibula, proximal tibia, knee, clavicle, scapula, olecranon, humerus, radius, ulna, calcaneus, femur.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162124, K093928, K083213, K082624, K081353, K080522, K071264, K062564, K061940, K052390, K050646, K050110, K033556, K032032, K031573, K030858, K030597, K023802, K013248, K011978, K010321, K001945, K001941, K000066, K991407, K983787, K964259, K963325, K791619, K063049

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image shows the date June 21, 2019. The text is in a simple, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year. The text is black against a white background.

DePuy Synthes Quinn McCarthy Regulatory Affairs Specialist II 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K190750

Trade/Device Name: see page 3, List of Cleared Devices in K190750 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, KTT, KTW, LXT, JDO, JDP Dated: March 22, 2019 Received: March 25, 2019

Dear Ouinn McCarthy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure:

List of Cleared Devices in K190750

2

List of Cleared Devices in K190750

• 1. DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension MR Conditional
• 2. DePuy Synthes 3.5 mm Quadrilateral Surface Plates MR Conditional
• 3. DePuy Synthes 2.7 mm / 3.5 mm LCP Distal Fibula Plates -MR Conditional
• 4. DePuy Synthes 3.5 mm LCP Posteromedial Proximal Tibia Plate 10H/183mm -MR Conditional
• 5. DePuy Synthes TornoFiX Medial Distal Femur Plates MR Conditional
• 6. DePuy Synthes 3.5mm LCP Distal Tibia T Plates MR Conditional
• 7. DePuy Synthes 2.4/2.7 mm Locking Foot Module MR Conditional
• 8. DePuy Synthes LCP Distal Femur Plates MR Conditional
• 9. DePuy Synthes LCP Ankle Arthrodesis Plates MR Conditional
• 10. DePuy Synthes LCP Proximal Tibia Plates Line Extension MR Conditional
• 11. DePuy Synthes 3.5 / 4.5mm LCP Medial Proximal Tibia Plates MR Conditional
• 12. DePuy Synthes LCP Modular Foot Plates MR Conditional
• 13. DePuy Synthes LCP Dynamic Helical Hip System MR Conditional
• 14. DePuy Synthes LCP Proximal Femur Hook Plates MR Conditional
• 15. DePuy Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate MR Conditional
• 16. DePuy Synthes LCP Proximal Femur Plate and Screws MR Conditional
• 17. DePuy Synthes 3.5mm Titanium LCP Proximal Tibia Plate MR Conditional
• 18. DePuy Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System MR Conditional
• 19. DePuy Synthes Locking Compression Plate System- MR Conditional
• 20. DePuy Synthes LCP Distal Tibia Plates MR Conditional
• 21. DePuy Synthes LCP Proximal Tibia Plate MR Conditional
• 22. DePuy Synthes Modular Foot System 2.7 mm Module MR Conditional
• 23. DePuy Synthes Medial Distal Tibia Plates MR Conditional
• 24. DePuy Synthes Modular Foot System- MR Conditional
• 25. DePuv Synthes Locking Calcaneal Plates MR Conditional
• 26. DePuy Synthes Proximal Tibia Plating System MR Conditional
• 27. DePuy Synthes DHS/DCS System Modification MR Conditional
• 28. DePuy Synthes Titanium Alloy High Tibial Osteotomy (HTO) System MR Conditional
• 29. DePuy Synthes Dynamic Hip Screw MR Conditional
• 30. DePuy Synthes 2.7 mm Condylar Plate- MR Conditional

3

510(k) Number (if known) K190750

Device Name

DePuy Synthes Modular Mini Fragment LCP System - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

4

510(k) Number (if known)

K190750

Device Name

DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

5

510(k) Number (if known) K190750

Device Name

DePuy Synthes 3.5MM QUADRILATERAL SURFACE PLATES - MR Conditional

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
--------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

6

510(k) Number (if known)

K190750

Device Name

DePuy Synthes 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

7

510(k) Number (if known) K190750

Device Name

DePuy Synthes 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE 10H/183MM - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CEB 801 Subpart D)
Over-The-Counter Use (21 CER 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

8

510(k) Number (if known) K190750

Device Name DePuy Synthes TOMOFIX MEDIAL DISTAL FEMUR PLATES - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

9

510(k) Number (if known) K190750

Device Name DePuy Synthes 3.5MM LCP DISTAL TIBIA T PLATES - MR Conditional

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

10

510(k) Number (if known)

K190750

Device Name

DePuy Synthes 2.4/2.7 MM LOCKING FOOT MODULE - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

11

510(k) Number (if known)

K190750

Device Name

DePuy Synthes LCP DISTAL FEMUR PLATES - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

12

510(k) Number (if known) K190750

Device Name

DePuy Synthes LCP ANKLE ARTHRODESIS PLATES - MR Conditional

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

13

510(k) Number (if known)

K190750

Device Name

DePuy Synthes LCP PROXIMAL TIBIA PLATES LINE EXTENSION - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

14

510(k) Number (if known)

K190750

Device Name

DePuy Synthes 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

15

510(k) Number (if known)

K190750

Device Name

DePuy Synthes LCP MODULAR FOOT PLATES - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

16

510(k) Number (if known)

K190750

Device Name

DePuy Synthes LCP DYNAMIC HELICAL HIP SYSTEM - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

17

510(k) Number (if known)

K190750

Device Name

DePuy Synthes LCP PROXIMAL FEMUR HOOK PLATES - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

18

510(k) Number (if known)

K190750

Device Name

DePuy Synthes 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

19

510(k) Number (if known)

K190750

Device Name

DePuy Synthes LCP PROXIMAL FEMUR PLATE AND SCREWS - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
XI Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

20

510(k) Number (if known)

K190750

Device Name

DePuy Synthes 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

21

510(k) Number (if known)

K190750

Device Name

DePuy Synthes 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
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CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

22

510(k) Number (if known)

K190750

Device Name DePuy Synthes LCP DISTAL TIBIA PLATES - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

23

510(k) Number (if known)

K190750

Device Name

DePuy Synthes LCP PROXIMAL TIBIA PLATE - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

24

510(k) Number (if known)

K190750

Device Name

DePuy Synthes MODULAR FOOT SYSTEM - 2.7 MM MODULE - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

25

510(k) Number (if known)

K190750

Device Name DePuy Synthes MEDIAL DISTAL TIBIA PLATES- MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

26

510(k) Number (if known)

K190750

Device Name DePuy Synthes Modular Foot System- MR Conditional

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

27

510(k) Number (if known)

K190750

Device Name

DePuy Synthes LOCKING CONDYLAR PLATE (LCP) SYSTEM- MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

28

510(k) Number (if known)

K190750

Device Name DePuy Synthes LOCKING CALCANEAL PLATES - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

29

510(k) Number (if known)

K190750

Device Name DePuy Synthes PROXIMAL TIBIA PLATING SYSTEM - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

30

510(k) Number (if known)

K190750

Device Name

DePuy Synthes DHS/DCS SYSTEM MODIFICATION - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over The Counter Use (21 CFR 801 Subpart C)

| > Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

31

510(k) Number (if known)

K190750

Device Name

DePuy Synthes TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

32

510(k) Number (if known)

K190750

Device Name

DePuy Synthes DYNAMIC HIP SCREW - MR Conditional

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

33

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension – MR Conditional

Classification Name(s): Condylar Plate Fixation Implant

Regulatory Class: Class II

Product Code(s): JDP, HWC

1.3. Predicate Device

K162124 - Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension

1.4. Device Description

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.

1.5. Indications for Use

34

The DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extraarticular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K162124. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

35

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes 3.5mm Quadrilateral Surface Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

1.3. Predicate Device

K093928 - SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES

1.4. Device Description

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.

1.5. Indications for Use

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

36

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K093928. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 3.5mm Quadrilateral Surface Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

37

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS, HWC

• 1.3. Predicate Device

K083213 - SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES

1.4. Device Description

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.

1.5. Indications for Use

38

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

Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K083213. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The nonclinical 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.

39

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

1.3. Predicate Device

K082624 - SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES

1.4. Device Description

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.

1.5. Indications for Use

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.

40

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K082624. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The nonclinical 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.

41

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes TomnoFiX Medial Distal Femur Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K081353 - SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES

1.4. Device Description

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.

1.5. Indications for Use

42

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.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K081353. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuv Synthes TomnoFiX Medial Distal Femur Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The nonclinical 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.

43

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes 3.5 mm LCP Distal Tibia T Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K080522 - SYNTHES 3.5MM LCP DISTAL TIBIA T PLATES

1.4. Device Description

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.

1.5. Indications for Use

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

44

Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K080522. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 3.5 mm LCP Distal Tibia T Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

45

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes 2.4/2.7 mm Locking Foot Module – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

1.3. Predicate Device

K071264 - SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE

1.4. Device Description

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.

1.5. Indications for Use

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

46

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K071264. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 2.4/2.7 mm Locking Foot Module in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

47

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes LCP Distal Femur Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K062564 - SYNTHES LCP DISTAL FEMUR PLATES

1.4. Device Description

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.

1.5. Indications for Use

DePuy Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar,

48

periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K062564. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes LCP Distal Femur Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

49

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes LCP Ankle Arthrodesis Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

1.3. Predicate Device

K061940 - DePuy Synthes LCP Ankle Arthrodesis Plates

1.4. Device Description

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.

1.5. Indications for Use

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

50

Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K061940. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes LCP Ankle Arthrodesis Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

51

1. 510(k) Summary

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes LCP Proximal Tibia System Line Extension - MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K052390 - SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION

1.4. Device Description

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.

1.5. Indications for Use

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

52

bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K052390. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes LCP Proximal Tibia System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

53

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes (USA) 3.5 / 4.5 mm LCP® Medial Proximal Tibia Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

1.3. Predicate Device

K050646 - SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES

1.4. Device Description

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.

1.5. Indications for Use

54

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

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K050646. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes (USA) 3.5 / 4.5 mm LCP® Medial Proximal Tibia Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The nonclinical 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.

55

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes LCP Modular Foot Plates - MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

1.3. Predicate Device

K050110 - SYNTHES (USA) LCP MODULAR FOOT PLATES

1.4. Device Description

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.

1.5. Indications for Use

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

56

Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K050110. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes LCP Modular Foot Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

57

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes LCP Dynamic Helical Hip System – MR Conditional

Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Regulatory Class: Class II

Product Code(s): KTT

• 1.3. Predicate Device

K033556 - SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM

1.4. Device Description

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.

1.5. Indications for Use

58

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.

Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K033556. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes LCP Dynamic Helical Hip System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

59

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes LCP Proximal Femur Hook Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K032032 - SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES

1.4. Device Description

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

1.5. Indications for Use

60

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

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K032032. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes LCP Proximal Femur Hook Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

61

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes 3.5 mm Low Profile Pelvic Reconstruction Plates – MR Conditional

Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Regulatory Class: Class II

Product Code(s): KTT, HRS

1.3. Predicate Device

K031573 - SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE

1.4. Device Description

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.

1.5. Indications for Use

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

Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K031573. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 3.5 mm Low Profile Pelvic Reconstruction Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The nonclinical 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.

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510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes LCP Proximal Femur Plate – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS, HWC

• 1.3. Predicate Device

K030858 - SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS

1.4. Device Description

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.

1.5. Indications for Use

DePuy Synthes LCP Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric,

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trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K030858. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes LCP Proximal Femur Plate in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

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510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes 3.5mm Titanium LCPTM Proximal Tibia Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K030597 - SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES

1.4. Device Description

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.

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

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K030597. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 3.5mm Titanium LCPTM Proximal Tibia Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The nonclinical 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.

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510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes Titanium 4.5mm LCP Proximal Tibia Plating System – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

1.3. Predicate Device

K023802 - SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM

1.4. Device Description

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.

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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

1.5. Indications for Use

The DePuy Synthes Titanium 4.5mm 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.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K023802. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Titanium 4.5mm LCP Proximal Tibia Plating System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The nonclinical 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.

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510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes Locking Compression Plate (LCP) System - MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K013248 - SYNTHES LCP DISTAL TIBIA PLATES

1.4. Device Description

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.

1.5. Indications for Use

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

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of the distal tibia and other small bones as a part of the DePuy Synthes Small Fragment LCP System.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K013248. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Locking Compression Plate (LCP) System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

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510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes LCP Proximal Tibia Plates - MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K011978 - SYNTHES LCP PROXIMAL TIBIA PLATE

1.4. Device Description

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.

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

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K011978. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes LCP Proximal Tibia Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

73

1. 510(k) Summary

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes Modular Foot System - 2.7 mm Module – MR Conditional

Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Regulatory Class: Class II

Product Code(s): KTW

• 1.3. Predicate Device
  K010321 - MODULAR FOOT SYSTEM - 2.7 MM MODULE

1.4. Device Description

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.

1.5. Indications for Use

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.

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Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K010321. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Modular Foot System - 2.7 mm Module in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

75

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes Medial Distal Tibia Plates are – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K001945 - SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

Device Description 1.4.

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.

1.5. Indications for Use

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

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K001945. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Medial Distal Tibia Plates are in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

77

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes Modular Foot System – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

1.3. Predicate Device

K001941 - Synthes Modular Foot System

1.4. Device Description

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.

1.5. Indications for Use

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

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Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K001941. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Modular Foot System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

79

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes (USA) 3.5/4.5 mm LCP Medial Proximal Tibia Plates – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS, HTY, HWC, JDW

• 1.3. Predicate Device
  K000066 - SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM

1.4. Device Description

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.

1.5. Indications for Use

The DePuy Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-

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articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K000066. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes (USA) 3.5/4.5 mm LCP Medial Proximal Tibia Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The nonclinical 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.

81

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes Locking Calcaneal Plates - MR Conditional

Classification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Regulatory Class: Class II

Product Code(s): LXT

1.3. Predicate Device

K991407 - SYNTHES LOCKING CALCANEAL PLATES

1.4. Device Description

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.

1.5. Indications for Use

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

Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K991407. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Locking Calcaneal Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

83

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes Proximal Tibia Plating System - MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K983787 - SYNTHES PROXIMAL TIBIA PLATING SYSTEM

1.4. Device Description

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.

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

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K983787. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Proximal Tibia Plating System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

85

1. 510(k) Summary

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes DHSIDCS One-Step Lag Screws SYSTEM MODIFICATION – MR Conditional

Classification Name(s): Device, Fixation, Proximal Femoral, Implant

Regulatory Class: Class II

Product Code(s): JDO, KTT

• 1.3. Predicate Device
  K964259 - SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION

1.4. Device Description

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.

1.5. Indications for Use

DePuy Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable and

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unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the K964259. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes DHSIDCS One-Step Lag Screws in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

87

1. 510(k) Summary

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes Titanium Alloy HTO System – MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): HRS

1.3. Predicate Device

K963325 - SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM

1.4. Device Description

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.

1.5. Indications for Use

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

88

the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation.

1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K963325. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Titanium Alloy HTO System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

89

510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact:

Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact:

Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes Dynamic Hip Screw - MR Conditional

Classification Name(s): Plate, Fixation, Bone

Regulatory Class: Class II

Product Code(s): KTT

• 1.3. Predicate Device

K791619 - DYNAMIC HIP SCREW

• 1.4. Device Description

1.5. Indications for Use

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.

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1.6. Substantial Equivalence

The purpose of this submission is to add MR Conditional information to the device labeling for the K791619. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Dynamic Hip Screw in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.

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510(k) Summary 1.

Date Prepared: March 22, 2019

1.1. Submitter

Primary Contact: Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: [phone] [e-mail]

1.2. Device

Name of Device: DePuy Synthes 2.7 mm Condylar Plate – MR Conditional

Classification Name(s): Single/multiple component bone fixation appliances and accessories

Regulatory Class: Class II

Product Code(s): HRS

• 1.3. Predicate Device

K063049 - DEPUY SYNTHES MODULAR MINI FRAGMENT LCP SYSTEM

1.4. Device Description

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.

1.5. Indications for Use

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

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Substantial Equivalence 1.6.

The purpose of this submission is to add MR Conditional information to the device labeling for the Preamendment. The intended use and technological characteristics of the devices remains unchanged.

Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 2.7 mm Condylar in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). 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.