360CAS

The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure can be identified. The 360CAS Knee is indicated for the following surgical procedures:
• Any form of Total Knee Arthroplasty (TKA)
• For conditions of the knee joint in which the use of computer assisted surgery may be appropriate
The 360CAS Hip is indicated for the following surgical procedures:
• Any form of Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used
• For conditions of the hip joint in which the use of computer assisted surgery may be appropriate

The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified. The 360CAS Knee is indicated for the following surgical procedures: • Total Knee Arthroplasty (TKA). • For conditions of the knee joint in which the use of computer assisted surgery may be appropriate. The 360CAS Hip is indicated for the following surgical procedures: • Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used. • For conditions of the hip joint in which the use of computer assisted surgery may be appropriate.

The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative guidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map subject's morphology, navigate surgical instruments and implants and assess state of the joint throughout the surgery. The system consists of 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g., pointer, bone fixator(s)). The subject device is predicated on submission (K213380). The modification driving the subject device submission relates to the change of the spatial tracking component sub-system. The previously cleared device incorporated a tracking camera manufactured by Metria Innovation Inc., whereas the subject device will utilise a tracking camera manufactured by Atracsys LLC.