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The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in Distal Tibial Medial Opening or Closing Wedge Osteotomy, Distal Tibial Lateral Closing Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip Activmotion S DTO Range.

Newclip Patient-matched instrumentation non sterile PSI are patient specific instrument (PSI) guides intended to assist in pre-operative planning and/or in guiding the marking of bone and/or surgical instruments in non-acute, non-joint replacing osteotomies about the knee and distal tibia. The PSI Guides are surgical drilling and cutting instruments that are designed to match the patient's anatomy. The PSI guides are additively manufactured, are single-use devices, and provided clean, nonsterile to the end-user. The purpose of this 510(k) is to obtain FDA clearance for PSI Guides for distal tibial osteotomies and facilitate implantation of Newclip Activmotion S DTO Range devices that were 510(k) cleared by the US FDA.

Material: Polyamide (PA2200).

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