APEX Knee System Retaining Bolt - Uncoated knee tibia prosthesis, metallic

Intended purpose

The APEX Knee System Retaining Bolt is a sterile component of ‘The APEX Knee System’, which is intended for use in primary and revision total knee replacement procedures only. The indications for use include: • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • Correction of functional deformity; and • Revisions procedures where other treatments or devices have failed.

Functional description

The APEX Knee System Retaining Bolt component is designed for use in the APEX Knee System only to connect the tibial insert (Congruent, Ultra, PS, PS-C, and PS-R) to the tibial baseplate (Primary or Modular). The device is manufactured from wrought annealed Ti-6Al-4V titanium alloy. For Congruent and Ultra inserts, there is only one sized locking bolt. The locking bolt for the PS, PS-C and PS-R inserts must match the thickness of the insert.