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SYNTHECEL® Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.

SYNTHECEL® Dura Repair is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SYNTHECEL® Dura Repair functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SYNTHECEL® Dura Repair is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.

The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for external fixation of fractured long bones and bones of the foot, limb lengthening, and deformity correction in adult, children* (3-12), and adolescent* (12-21) patient populations. The DePuy Synthes MAXFRAME™ Multi- Axial Correction System utilizes software for assisting surgeons in treatment planning. *in which the growth plates have fused or will not be crossed. The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: • fracture fixation (open and closed) • pseudoarthrosis of long bones • limb lengthening (epiphyseal or metaphyseal distraction) • joint arthrodesis • infected fractures or nonunions • correction of bony or soft tissue deformities • correction of segmental defects.

The DePuy Synthes MAXFRAME™ Multi Axial Correction System, is an external ring fixation system that consists of MAXFRAME Hardware (schanz screws, pins, struts, rings) and MAXFRAME Web Software, used in treatment of soft tissue and bone deformities. The subject device MAXFRAME 3D II Software (Moderate Software Level of Concern) is a software re-write of the MAXFRAME Web Software to make it more efficient, simplify software upgrades for functionality and fixing of software anomalies or bugs. Additionally, based on surgeon feedbacks and voice of customer, new functionality has been added around how frames are identified on X-Rays/radiographic images and how the treatment of the deformity can be planned.

The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.

The DePuy Synthes Variable Angle Locking Patella Plating System is comprised of single-use, sterile implants which will be placed on the lateral rim and on the anterior surface of the fractured patella to provide fixation during bone healing. The system offers both a small and a large plate to provide fixation for various patella fracture patterns. The subject plates are available sterile and are manufactured from implant grade stainless steel or titanium. The system also consists of sterile, non-implantable templates that correspond to the implants. Templates are intended to help determine proper sizing and help predict contoured shape of the implant.

DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates are indicated for the treatment of periprosthetic fractures in the presence of intramedullary implants in the proximal end segment and the proximal and middle 1/3 of the diaphyseal segment of the femur, and non-unions of such fractures, in adult patients, particularly in osteoporotic and osteopenic bone. DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to augment the stabilization of fractures, including periprosthetic fractures (Vancouver Type B when used with either the 3.5 mm VA-LCP PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver Type B and C when used with other DePuy Synthes LCP plates and VA-LCP plates) and fractures in the presence of intramedullary implants, in the femur, tibia, and humerus. DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates (when used with either 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be used to extend the length of a plate construct to the lateral condyles. DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates (when used with 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate) are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy. DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.

The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System of Stainless Steel Plates for periprosthetic fractures. It consists of plates that offer screw to plate non-locking constructs, locking constructs or a combination of both. The plates accept commercially available DePuy Synthes Stainless Steel 3.5 mm cortex screws, 3.5 mm (variable angle) locking screws, 4.5 mm cortex screws and 5.0 mm (variable angle) locking screws, as well as the Synthes Orthopaedic Cable system. The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System offers: • 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates • 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Hook Plates • 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plate • 3.5 mm VA Locking PPFx Greater Trochanter Hook Plate • 3.5 mm VA Locking PPFx Greater Trochanter Ring Attachment Plate • 3.5 mm VA Locking Attachment Plate

The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including: - Supracondylar fractures, including those with intra-articular extension - Combination of ipsilateral condylar and diaphyseal fractures - Ipsilateral femur/tibia fractures - Femoral fractures in multiple trauma patients - Periprosthetic fractures - Fractures in the morbidly obese - Fractures in osteoporotic bone - Impending pathologic fractures - Malunions and nonunions The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails.

The proposed Retrograde Femoral Nail Advanced System is being developed to address challenges associated with treating distal femur fractures with intramedullary nails. The system is modular in nature, incorporating several components to allow for the treatment of a variety of fracture patterns and in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two different bends which enable standard and periprosthetic entry points for the insertion of the nailing implant in the femur. The implants in this submission are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions. The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm feature a retaining screw head recess, additional shorter, rounded cutting flutes the ability to drive under power. The screws feature either a standard screw head or a low-profile screw head and are available with standard washers and nuts.

The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

The Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and sizes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only. The Synthes MatrixMANDIBLE screws that are the subject of this submission are made from titanium alloy (Ti-6Al-7Nb) and are available in a diameter of 2.4 mm and lengths ranging from 26-40mm, and have a thread pitch of 1.0 mm. These screws work with all plates within the MatrixMANDIBLE Plate and Screw system. These devices are offered non-sterile and must be sterilized before use. MatrixMANDIBLE screws are intended for single use only.

The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.

The DePuy Synthes Variable Angle Locking Patella Plating System is comprised of implants which will be placed on the anterior surface of the fractured patella to provide fixation during bone healing. The system offers three plate configurations, in two sizes, to provide fixation for various patella fracture patterns and are available in implant grade stainless steel and titanium. The system also consists of sterile, non-implantable templates that correspond to the implants. Templates are intended to help determine proper sizing and help predict contoured shape of the implant.

DePuy Synthes Tibial Nail Advanced System: The Tibial Nail Advanced implants are intended for treatment of fractures in adolescents (12-21) in which the growth plates have fused. Specifically, the implants are indicated for: - · Open and closed proximal and distal tibial fractures - Open and closed tibial shaft fractures - · Tibial malunions and nonunions DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm: DePuy Synthes Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails.

DePuy Synthes Tibial Nail Advanced System: The DePuy Synthes Tibial Nail Advanced System is a system comprised of intramedullary nails, locking screws, end caps implants, as well as system-specific insertion instruments. The Tibial Nail Advanced System is intended to be used for temporary fixation and stabilization of tibia. This system enables three different surgical approaches for the insertion of the nailing implant in the tibia: suprapatellar. parapatellar, and infrapatellar. The implants are manufactured from titanium alloys and provided in a range of dimensions to match individual patient anatomy. The intramedullary nailing implants are cannulated and can be inserted over a reaming rod. The nailing implants are offered in a range of proximal and distal shaft diameters and lengths to accommodate patient anatomy and surgical need related to the specific fracture patterns and locations. The nails will be manufactured from titanium alloy (Ti-6Al-4V) and polyetherketone (PEEK). DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm: The DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm have a diameter of 5 mm available in lengths ranging from 26 up to 120 mm and a diameter of 4 mm available in lengths ranging from 18 up to 80 mm. These implantable devices are fully threaded at the shaft and are self-tapping. The locking screws feature either a standard screw head or a low-profile screw head. The screws are made from titanium alloy (Ti-6Al-7Nb).

The DePuy Synthes Hammertoe Continuous Compression Implant is indicated for small bone reconstruction and fusion of the phalanges in the toes.

The implants of the DePuy Synthes Hammertoe Continuous Compression Implant System are made of biocompatible Nitinol and are designed to exhibit pseudoelastic (superelastic) properties at room temperature. Each implant is supplied pre-loaded on an insertion stick assembly in a constrained state, with the legs parallel. It is inserted into pre-drilled holes and released utilizing the insertion slider and if necessary, impaction on the proximal end of the insertion stick. Upon release, the implants attempt to return to their original unconstrained shape and thus provide compression to the bones across the osteotomy or arthrodesis site. The implants do not require any external heating; they are completely transformed at ambient temperature. In good bone quality, this deflection may not be visible as the legs are constrained by the surrounding tissue. The implant is offered in two (2) sizes to address varying patient anatomy of the foot. The implant is delivered to the operating room in a disposable, sterile kit, preloaded onto a handheld insertion stick assembly along with a drill pin, drill guide, locator pins and K-wires.

The TOMOFIX™ Medial High Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures, and malalignment caused by injury or disease of the medial proximal tibia for the treatment of: Unicompartmental medial or lateral gonarthrosis with malalignment of the proximal tibia Idiopathic or posttraumatic varus or valgus deformity of the proximal tibia

The subject Titanium TomoFix™ Medial High Tibia Plate Anatomical is anatomically precontoured to fit the medial side of the proximal tibia (also referred to as high tibia) and is provided in a 'left' and 'right' version to accommodate the anatomy of the tibia in the left and right knee, respectively. The plate features seven round, threaded locking holes to provide a locked, fixed-angle construct and one combination locking / dynamic compression hole to allow temporary compression during the surgery. The subject plate is designed to accept existing, previously cleared 5.0 mm Locking Screws, 4.5 mm Cortex Screws and 5.0 mm Spacers