Device typeDiaphysis prosthesis: An artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.
FDA categoryInstrument, Clip Forming/Cutting
Device ID04048266166692
Catalog numberGB41013S
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Outer Diameter10 Millimeter
Length130 Millimeter