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The Cannulated Screws Neoortho are generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. The Cannulated Screws Neoortho are also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections. Accessories implants: The washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.

The Neoortho Cannulated Screws include nine cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping screw with a cancellous or cortical thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system. The technological characteristic of the Neoortho Cannulated Screws are similar to the predicate devices including design, dimensions, and materials. The Neoortho cannulated screws and washers are fabricated from stainless steel per ASTM F138 and Ti-6Al-4V alloy per ASTM F136. The stainless steel and Ti-6Al-4V are commonly used material in orthopedic implants.

Intramedullary Nail and Screws for Femur - NEONAIL is indicated for femoral fracture fixation including: - · Open and closed femoral fractures; - · Pseudoarthrosis and correction osteotomy; - · Pathologic fractures, impending pathologic fractures, and tumor resections; - · Ipsilateral femur fractures; - · Fractures distal to the hip joint; and - Nonunions and malunions. Intramedullary Nail and Screws for Tibia - NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions or nonunions of the tibia. Intramedullary Nail and Screws for Tibia - NEONAIL is indicated for tibial fracture fixation, which may include: - · Open and closed tibial fractures; - · Pseudoarthodlosis and correction osteotomy; - · Pathologic fractures, impending pathologic fractures and tumor resections; and - · Nonunions and malunions. The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.

An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Intramedullary Nail and Screws – NEONAIL consists of metal rods, bone screws, and end caps. All components are made from Ti-6AI-4V alloy. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.

The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and ALIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S1, in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have Grade 1 Spondylolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment prior to treatment in the lumbar spine. The PLIF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine. The Cervical devices are indicated for spinal fusion procedures at one level in the cervical spine from C3 to T1 for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine. All lumbar and cervical devices are intended for use with autogenous bone graft.

The PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK -Optima (per ASTM F2026).

Small and Large Fragments Osteosynthesis System NEOFIX is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, carpals, metacarpals, distal femur, proximal tibia, tibial pilon, fibula, calcaneus, tarsals and metatarsals; small fragments of the hand and wrist; pelvis and acetabulum fractures; periprosthetic fractures; metatarsal and phalangeal osteotomies; and carpal, metacarpal, wrist and ankle arthrodesis. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.

NEOFIX consists of plates and screws in a variety of designs and sizes and made from commercially pure titanium or Ti-6Al-4V alloy. Plates are provided in straight designs and in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws designs. Screws are provided in cortical (locking and non-locking) and cancellous thread designs in various diameters and lengths.

Mini and Micro Fragments Reconstruction System – NEOFACE is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

Mini and Micro Fragments Reconstruction System – NEOFACE is a fixation system for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. It consists of implant plates and implant screws. The plates of the subject system include mini and micro fragment reconstruction plates. Plates are made of commercially pure titanium and screws are made of titanium alloy.