Manufacturer
Globus Medical, Inc.ExcelsiusFlex™
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K240721
- Device name
- ExcelsiusFlex™
- Company
- Globus Medical, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-03-18
- Decision date
- 2024-06-14
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Knee SurgeryNavigation SystemOther
- Primary application
- Knee Surgery
- Classification source
- AI classified
Indications for Use
ExcelsiusFlex™ when used in conjunction with ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons for navigating and/or guiding compatible surgical instruments provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or directly acquired anatomical structures. The system is indicated to assist the surgeon in planning the position of the implant components and preparing the bony anatomy during orthopedic procedures. The Total Knee Arthroplasty (TKA) implant systems compatible with ExcelsiusFlex™ are GENflex2® and ACTIFY™ Total Knee System. The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans, fluoroscopy or directly acquired anatomical structures. The system is indicated for the planning of orthopedic devices and placement of spinal and orthopedic bone screws and interbody fusion devices.
Intended Use
ExcelsiusFlex™ when used in conjunction with ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of a tool holder to be used by surgeons for navigating and/or guiding compatible surgical instruments provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or directly acquired anatomical structures. The system is indicated to assist the surgeon in planning the position of the implant components and preparing the bony anatomy during orthopedic procedures. The Total Knee Arthroplasty (TKA) implant systems compatible with ExcelsiusFlex™ are GENflex2® and ACTIFY™ Total Knee System.
Device Description
The ExcelsiusFlex™ is a robotic positioning system with a computer controlled robotic arm, hardware and software that works in conjunction with ExcelsiusHub™, to enable real time surgical navigation and robotic guidance using patient tracking arrays and a positioning camera. The system assists the surgeon in implant placement planning and intraoperative tracking of patient anatomy by locating anatomical structures and stereotaxic positioning of surgical instruments relative to patient CT images or directly acquired anatomical structures. The navigation and guidance system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy), or directly acquired anatomical structures. Once this registration is created, the software positions the robotic arm on a planned resection plane. The ExcelsiusFlex™ is intended for stereotaxic surgery in surgical knee procedures to assist the surgeon in spatial positioning and orientation of a sagittal sawblade, planning the position of the femoral and tibial implants, and for bone preparation during total knee arthroplasty (TKA) procedures. The system constrains the position of the robotic arm to planned resection planes based on the pre-operative or intra-operative plans developed using ExcelsiusFlex™-TKA software on either the ExcelsiusHub™ or a planning laptop. ExcelsiusFlex™ instruments consist of patient tracking instruments, patient attachment instruments, navigation instruments, end effectors and end effector instruments. Patient attachment instruments provides a point of rigid fixation for the patient tracking instruments. Patient tracking instruments and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. End effectors attach to the distal end of the robotic arm and provide a rigid connection to the saw blade.
Summary parsed at:2026-06-19 05:32:10 UTC
