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The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures

The subject system is a line extension that includes clavices (superior lateral, anterior mideral, and anterior midshaft) and additional locking and non-locking screws (2.1mm, and 2.7mm diameter). The plates and screws are fabricated from either medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.

The OsteoCentric Cannulated Fasteners and Nuts is indicated for use in bone reconstruction, osteotomy, arthrodesis (joint fusion), and fixation of fractures and ligaments: The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The OsteoCentric 3.5mm Cannulated Screws are intended for the arthrodesis or fixation of fractures and fragments of hand, midfoot, and forefoot bones, extremity osteochondritis dissecans lesions, and for extremity ligament fixation. The OsteoCentric 4.5mm to 8.0mm Cannulated Screws are intended for fixation of long bone fractures and fragments. Iong bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, pediatric femoral neck fractures, intercondylar femur fractures, fixation of the pelvis and pelvic joints, and arthrodesis (e.g., ankle, subtalar). The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for reduction and stabilization of fractures or inter-osseous distances (e.g. syndesmosis injuries).

The OsteoCentric Technologies Cannulated Fasteners and Nuts come in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The fasteners are provided non- sterile and are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295. Instrumentation is also provided non-sterile to properly insert the OsteoCentric Technologies Cannulated Fasteners and Nuts. All instrumentation is intended to be reusable, with the exception of the guidewires are provided non-sterile and are intended for single-use only.

The OsteoCentric Dental Implants are indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The OstecCentric Implants are indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading. The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.

The OsteoCentric Dental Implants consist of self-tapping and threaded endosseous implants with root-form or wide thread forms, and cover screws. The root-form implant diameters range from 3.5 mm to 5.5 mm (8 mm to 14 mm lengths) and the wide thread implant diameters are available in 4.1 mm and 4.5 mm (8 mm lengths), 5.5 mm (8 mm to 12 mm lengths), and 6.5 mm (8 mm to 10 mm lengths). The specific diameters and length combinations are specified below: - Root Form Implants: - Ø 3.5/ 8, 10, 12, and 14 mm - Ø 4.0/ 8, 10, 12, and 14 mm - Ø 4.5/ 8, 10, 12, and 14 mm - Ø 5.0/ 8, 10, 12, and 14 mm - Ø 5.5/ 8, 10, 12, and 14 mm - Wide Form Implants: - Ø 4.1/ 8, 10, 12, and 14 mm - Ø 4.5/ 8, 10, 12, and 14 mm - Ø 5.5/ 8, 10, and 12 mm - Ø 6.5/ 8 and 10 mm Cover screws provide protection to the threads of the connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. The OsteoCentric dental implants and cover screws are provided sterile. The implants, and cover screws are manufactured from titanium alloy (Ti-6A1-4V ELI; ASTM F136) or wrought titanium alloy (Ti-6Al-4V; ASTM F1472). The OsteoCentric Dental Implants are intended for use with compatible abutments and healing caps manufactured by Implant Logistics.

The Integrity-SI® Fusion System is intended for sacroiliac joint fusion for the following conditions: - Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months. - To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. - Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The Integrity-SI® Fusion System consists of partially and fully threaded, self-tapping cannulated titanium implants designed to be inserted across sacroiliac joint providing stability for joint arthrodesis when used in conjunction with allograft or autograft. The surgical implants are available in various sizes to accommodate patient anatomy. The 8 mm, 10 mm, and 12 mm diameter screws are offered in partially and fully threaded version in lengths from 40 - 1 10 mm, in 2.5 mm increments and are available in non-coated or hydroxyapatite-coated (HA) versions. The screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5 mm diameter, optional, secondary fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5 mm increments and are only intended for use in conjunction with a primary 8 mm, 10 mm, or 12 mm screw. The screws are provided in sterile and non-sterile options.

The OsteoCentric ACL Fixation Fasteners are used to provide bone fixation in orthopedic procedures, including bonetendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.

The OsteoCentric ACL Fastener System consists of ACL Fixation Fasteners and select singleuse and reusable instrumentation to facilitate implantation. The ACL Fixation Fasteners are threaded titanium interference screws with a tapered tip for easy insertion into bone. The fasteners are cannulated to allow the use of a guidewire to assist with placement of the fastener into the bone tunnel. The fastener is used to maintain the fixation of bone-tendon-bone grafts in orthopedic procedures. The ACL Fixation Fasteners are provided sterile. ACL Fixation single-use instruments are: a 2.4mm OD stainless steel drill-tipped passing pin, a 1.6mm OD nitinol guidewire, and a stainless-steel graft retractor. The ACL single-use instruments are provided sterile. ACL Fixation reusable instruments are: a 2.5mm hex driver, and a 3.5mm Hex Driver. The ACL Fixation reusable instruments are provided non-sterile and must be sterilized prior to use.

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 Integrity-SI Fusion System is intended for sacroiliac joint fusion for the following conditions: 1. Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months. 2. To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. 3. Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

The Integrity-SI Fusion System consists of partially and fully threaded, self-tapping cannulated titanium implants designed to be inserted across sacroiliac joint providing stability for joint arthrodesis when used in conjunction with allograft or autograft. The surgical implants are available in various sizes to accommodate patient anatomy. The 10mm and 12mm diameter screws are offered in partially and fully threaded version in lengths from 40-110mm, in 5mm increments. All fastener sizes are available in non-coated or hydroxyapatite-coated (HA) versions. The 10mm and 12mm screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5mm diameter, optional secondary fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5mm increments and are only intended for use in conjunction with a primary 10mm or 12mm screw.

The OsteoCentric Spine MIS Pedicle Fastener System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The OsteoCentric Spine MIS Pedicle Fastem is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the OsteoCentric Spine MIS Pedicle Fastener System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origins with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); turnor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The OsteoCentric Spine MIS Pedicle Fastemer System is a posterior fusion spinal fixation system which consists of non-sterile pedicle fasteners (Ø4.5 - 08.5, 25 - 180 mm), cannulated pedicle fasteners (05.5 - 08.5, 25 - 100 mm), reduction fasteners, extended tab implants, locking caps, and rods (05.5, 30 - 180 mm). The fasteners are used to attach the system components to the non-cervical spine and allows a surgeon to build an implant construct with the intent to stabilize the operative site during the fusion process. The implant components are manufactured from titanium alloy (ASTM F136).

The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The OsteoCentric 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodesis of the carpals and phalanges, steochnondritis dissecans, and ligament fixation. The OsteoCentric 4.5mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments. The OsteoCentric 6.5mm to 8.0mm Cannulated Screws are intended for fracture fixation of long bones and long bone fragments, long bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, SI joint disruptions, fixation of pelvis and iliosacral joints, and subtalar arthrodesis. The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (e.g. syndesmosis) as long as there is not increased morbidity associated with the insertion of a nutand-bolt system, as discussed above.

The OsteoCentric Technologies Cannulated Fasteners and Nuts consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws and nuts are provided non-sterile. The screws and nuts are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295. The purpose of this submission is to modify the indications for use.

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.