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RESPONSE™ Navigation Instruments are intended to be used during the preparation and placement of Response 4.5/5.0 and 5.5/6.0 Spine System pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic® StealthStation® S8 System (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The OrthoPediatrics RESPONSE™ Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants. The RESPONSE™ Navigation Instruments include taps, probes, and drivers. The RESPONSE™ Navigation Instruments are to be used with the RESPONSE™ Spine System. All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø3mm to Ø8mm. The RESPONSE™ Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation® Navigation System hardware and software.

The OrthoPediatrics Pediatric Nailing Platform|Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; prophylactionalling of impending pathologic fractures; nonunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Additional indications includes simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics Pediatric Nailing Platform|Femur is for single use only.

The proposed OrthoPediatrics Pediatric Nailing Platform|Femur seeks to add sterile packaged nails for distribution. All subject components have previously been cleared as non-sterile implants. All other components of the OrthoPediatrics Pediatric Nailing Platform|Femur will remain non-sterile to be sterilized by end-user. The OrthoPediatrics Pediatric Nailing Platform|Femur nails have a complex 3-dimensional geometry resulting in an anatomically appropriate design which with an advanced surgical technique. The smaller diameter of the nail allows it to be inserted in patients with a narrow medullary canal and allows for easier insertion without the need for excessive reaming. The proposed nails are manufactured from stainless steel conforming to ASTM F138 and are available in child and adolescent configurations: - The child nails are available in 7mm, 8mm, and 9mm diameters. - The adolescent nails are available in 9mm, 10mm, 11mm, and 12mm diameters. - These nails range in length from 20cm to 42cm, depending on the naildiameter. - Surgeon preference dictates the appropriate nail size required to stabilize the fracture and allow for appropriate healing.

The OrthoPediatrics Titanium PediPlates® System is used for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia), valgus, varus, or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The OrthoPediatrics Titanium PediPlates® System consists of two and four-hole plates featuring a contoured mid-section and a low profile for pediatric use. There is a small provisional fixation hole in the center of the O and I-Plates to aid in accurate placement of the device relative to the growth plate. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is affixed to the bone using two to four screws (solid and cannulated), depending on which plate is selected.

The OrthoPediatrics Locking Proximal Femur System Cortical Screws are intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and Varus osteotomies, femoral neck and pertrochanteric fractures, and intertrochanteric valgus osteotomies.

The OrthoPediatrics Locking Proximal Femur System Cortical Screws are a line extension to expand the current offering to allow for longer cortical screws. The screws are part of one system that combines implants (plates and screws) and instruments. The additional cortical screw sizes include the following: 55mm, 60mm, 65mm, 70mm, 75mm, and 80mm.

OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unions, and non-unions in all pediatric subgroups (except neonates), and small stature adults.

The OrthoPediatrics' PediLoc Fragment System combines implants and instruments in one convenient and comprehensive system. This System provides immediate stability and temporary fixation of bones during the healing process with conventional plating technology and fixation techniques.

The OrthoPediatrics ACL Reconstruction System is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.

The OrthoPediatrics ACL Reconstruction System is a two part fixation system for anchoring soft tissue grafts in ACL deficient patients. It is available in diameters of 6mm, 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, & 10mm in order to accommodate differing anatomic requirements. The first system is a screw designed to work in conjunction with a sleeve that has been fitted into the graft tunnel within the bone. Both screw and sleeve components are made entirely of PEEK Optima. The second system consists of a titanium alloy implant intended to hook onto the looped portion of the soft tissue graft and then rest onto the cortex at the end of the graft tunnel.

The Response Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

The Response Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes, including fixed angled screws, to accommodate differing anatomic requirements.

The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The device is intended to be used with autograft and/or allograft.

The OP Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/flium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

The OP Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of -sizes to accommodate differing anatomic requirements.

OrthoPediatrics PediLoc™ Tibia Plates are indicated for fractures, osteotornies, and non-unions of the pediatric and small stature adult tibia.

The OrthoPediatrics PediLoc™ Tibial Plates 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.