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AutoStrut G2 is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and 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 AutoStrut G2 is comprised of control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the AutoStrut G2 motorized struts. The MAXFRAME was cleared with software that generates a treatment plan for the patient, detailing how much each strut should be extended after a given amount of time. The output of this software is downloaded to the AutoStrut G2 control box which will then automatically extend the motorized struts the predetermined amount at the prespecified times. The AutoStrut G2 struts are provided in three (3) sizes, Large, Medium and Small corresponding to the MAXFRAM and should be steam sterilized by the user prior to use.

AutoStrut is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused and 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.

AutoStrut is comprised of six length-adiustable struts powered by a motor, a control system and software. The device is used in conjunction with the predicate DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software but the MAXFRAME struts are substituted with the AutoStrut motorized struts.