Benchmed logo
Categories

360CAS

Kico Knee Innovation Company Pty, Ltd.

Country / Region:Australia (AU)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K213380
Device name
360CAS
Country / Region
Australia(AU)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2021-10-13
Decision date
2022-01-11
Submission type
Traditional
Technology type
Image Guided Surgery(AI inferred)
Clinical applications
Knee SurgeryOther
Primary application
Knee Surgery
Classification source
AI classified

Indications for Use

The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures.

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

Intended Use

The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures. 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 Total Knee Arthroplasty (TKA) and for conditions of the knee joint in which the use of computer assisted surgery may be appropriate. The 360CAS Hip is indicated for Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used, and for conditions of the hip joint in which the use of computer assisted surgery may be appropriate.

Device Description

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 a patient's morphology, navigate surgical instruments and implants and assess the state of the joint throughout the surgery. The system consists of four main components: 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)).

Summary parsed at:2026-06-24 04:14:51 UTC

Predicate devices

3

K213380 references 3 predicate/reference devices

Cited as predicate

1

1 submission cite K213380 as a predicate