Search Results

The OrthoPediatrics PediNail Intramedullary Platform is used for pediatric and stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; psilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunion; 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; supracondy|ar fractures; bone lengthening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics PediNail Intramedullary Platform is for single use only.

The OrthoPediatrics PediNail Intramedullary Nailing System (K083726) consists of a rigid stainless steel nail and stainless steel screws. The proposed OrthoPediatrics PediNail Intramedullary Platform seeks to broaden the reach of the PediNail brand by offering additional nail diameters, screws, nails designed specifically for child and adolescent, and improved instrumentation. The proposed device is composed of the intramedullary fixation rods (nails) with screw holes at either end for fixation to bone, screws, interlocking pegs, and end caps coupled with device-specific instruments including the Modular Necks, the Targeting Guides, the Attachment Bolts, the Derotation Dial Targeting Guide Attachment, the AP Nail Positioning Jig, the AP Position Templates, the Impactors, and the Nail Extractor Adaptor. The OrthoPediatrics PediNail Intramedulary Platform nails have a complex 3-dimensional geometry resulting in an anatomically appropriate design. 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.

OrthoPediatrics Wrist Fusion Plates are intended for wrist arthrodesis and fractures of other small bones in children, adolescents, and small stature adults. Specific indications include post-traumatic arthritis of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.

OrthoPediatrics Wrist Fusion Plates are provided non-sterile, are available in two lengths, 99mm and 112mm, to accommodate a patient with or without a Proximal Row Carpectomy (PRC). The Wrist Fusion Plates accept 2.7mm screws both distally and in the capitate, and 3.5mm screws proximally. These screws were previously cleared in the PediLoc Fragment System 510(k), K140431. In additional to the two wrist fusion plates, bending templates are included to assist with intra-operative contouring of the plate into either dorsiflexion or palmar flexion.