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The OsteoCentric Integrated Hip Fastener System is indicated for stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed. The OsteoCentric Integrated Hip Fastener System is indicated for femoral neck fractures including intracapsular, transcervical, and subcapital fractures.

The OsteoCentric Integrated Hip Fastener System is internal fixation of intertrochanteric and femoral neck fractures of the proximal femur. The OsteoCentric Integrated Hip Fastener System consists of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. Integrated Hip Fasteners which are lag screws implanted through the femoral neck and head are offered in Ø11, Ø13, & Ø15mm sizes with lengths ranging from 50 – 140mm in 5mm increments. Hip side plates are offered in 1-hole to 19-hole configurations (48 – 330mm length). 6.0mm support fasteners are offered in 55 – 125mm lengths. 5.2mm shaft fasteners are offered in 28 – 46mm locking fasteners for the trochanter plate are offered in 16 – 40mm lengths. Compression and attachment screws are also available. Devices are provided non-sterile. All implantable devices are manufactured from stainless steel per ASTM F138.

The EVOS MINI Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The EVOS MINI Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, and clavicle. The EVOS Partial Articular and Anti-Glide Plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula. The EVOS Wrist Fracture Plating System is indicated for adult and pediatic patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna. The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures. The PERI-LOC Plate and Screw System can be used for adult and pediativ patients with osteopenic bone. PERI-LOC bone plates and bone screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, humerus, ulna, radius, calcaneus, and clavicle. PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatic patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and for fracture fixation of the firstion of the firstilula. PERI-LOC VLP One-Third Tubular Locking Plates are indicated for, but not limited to, fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals. PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures of the proximal femur including metastatic fractures: proximal fenur osteotonies: fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures. The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot. The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus. The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The VLP MINI-MOD Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot. The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius. The D-RAD SMART PACK System is intended for the fixation of fractures involving the distal radius. Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatic as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation. 1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.) 2. Trochanteric or subtrochanteric fractures with appropriate additional precautions about weight bearing and more than sedentary activity. 3. Osteotomies for patients with diseases or deformities of the hip. 4. Hip arthrodesis. 5. Supracondylar fractures and distal femoral fractures using a supracondylar plate. 6. Ipsilateral femoral shaft/neck fractures. CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures. The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metatarsals, patella, ultar styloid, capitellum, radial head and radial styloid. The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle. The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bone fragments; arthrodeses of small ioints; bunionectomies and osteotomies; scaphoid and other carpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The Smith & Nephew 2.0mm OFX Screw is indicated for osteotomies of the lesser metatarsals, such as Well osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.

The purpose of this Traditional 510(k) is to update the MR safety information for the Smith & Nephew Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modification has been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices.

The OsteoCentric Integrated Hip Fastener System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

The OsteoCentric Integrated Hip Fastener System is intended for use in internal fixation of femoral neck fractures. The OsteoCentric Integrated Hip Fastem consist of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided non-sterile. All implantable devices are manufactured from Stainless Steel per ASTM F138.

The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional sizes of the bone plates to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for singleuse. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

The THP™ Hip Fracture Plating System is indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures.

THP Hip Fracture Plating System is a set of metal plates and associated screws designed to affix to the lateral aspect of the proximal femur and provide fracture stabilization for femoral neck fractures and intertrochanteric fractures. The THP 5.0mm Cortical Screws are both locking and non-locking. The locking screws contain external threads that can be used to lock the threaded holes on the plate body, while the non-locking screws do not include the external threads to complete this task.

The Smith & Nephew Conquest FN is indicated for displaced intracapsular femoral neck fractures. The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional lengths of the proximal locking compression screws to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The subject internal fixation plating system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. All described implant devices are manufactured from implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies.

The TSP Hip Fracture Plating System consists of a series of side specific fracture plates designed to treat femoral neck, intertrochanteric and subtrochanteric fractures. The TSP Hip Fracture Plating System incorporates fracture plates with multiple cortical screw hole configurations, three 7.5mm telescoping lag screws in lengths from 70mm to 130mm that are inserted into the femoral head and lock into the fracture plate, and 4.5mm cortical screws in lengths ranging from 14mm to 95mm with either locking or non-locking head designs. The plates, lag screws and cortical screws are all made of Ti-6A1-4V titanium alloy with a TiMax® Type II anodized finish. Limited collapse sleeves are also available in 5mm, 10mm, 15mm and 20mm lengths to limit the amount of distraction of the telescoping lag screws.

Indications for the HipLOC™ Compression Hip Screw include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures.

The HipLOC™ Compression Hip Screw is designed as an internal fixation device to provide alignment and strong stabilization for fractures of the proximal femur.

1. ) Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head). 2.) Intertrochanteric fractures. 3.) Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored. 4.) Hip osteotomy Components in the InterTANTM CHS Plating System are for single use only.

The design of the InterTAN™ CHS Plating System is based on design features of the following currently marketed products: PERJ-IJOC™ Periarticular Locked Plating System, TriGen InterTAN Nail and CHS. InterTAN™CHS System is designed to address fractures of the proximal femur. System components include bone plates, lag screws, compression screws, and associated accessories. Like the predicate devices listed below, the subject components include various hole configurations and barrel angles of the contoured locking bone plates and various lengths of the lag/compression screws made from stainless steel and titanium. Further InterTAN™ CHS femoral locking bone plates, incorporate a screw-to-plate locking feature along the shaft of the plate which forms a locked, fixed angle construct to aid in holding fracture reduction.