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Supporting Documentation
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Software User Manual
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MAXFRAME 3D II Software User's Manual
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Indication Statement
Intended Use
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is intended for external fixation of fracture long bones and bones of the foot, limb lengthening, and deformity correction in adult, children* (3-12), and adolescent* (12-21) patient populations. The DePuy Synthes MAXFRAME Multi-Axial Correction System utilizes software for assisting surgeons in treatment planning.
*In which the growth plates have fused or will not be crossed.
Indications
The MAXFRAME System is indicated for the following treatments in adults and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or 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
Contraindications
MAXFRAME is not intended for use in the spine.
095016-180712
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