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510(k) Data Aggregation
(270 days)
The VSP Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies in the distal femur, tibia, and non-sacrum pelvis of adults and skeletally mature adolescents of normal stature.
The VSP Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures. The system contains several physical and digital outputs including patient-specific anatomical models, templates, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs).
Outputs of the VSP Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.
The VSP Orthopedics System also contains Stainless Steel Drill Inserts (VSP Orthopedics System Accessories) which are intended to be used by the physician to guide drilling activities during the surgical procedure. The inserts fit into a standard hole in the cutting / drill guides and can be used across all VSP Orthopedics System guides and templates.
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