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CUVIS-joint (CJ150)

Curexo, Inc.

Country / Region:Korea, Republic of (KR)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Korea, Republic of (KR)

Product code

OLO
21 CFR 882.4560

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K252037
Device name
CUVIS-joint (CJ150)
Country / Region
Korea, Republic of(KR)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2025-06-30
Decision date
2026-03-25
Submission type
Traditional
Technology type
Robotic Navigation(AI inferred)
Clinical applications
Knee SurgeryRobotic Assistance
Primary application
Knee Surgery
Classification source
AI classified

Indications for Use

The CUVIS-joint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA). The CUVIS-joint is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made. The CUVIS-joint is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The CUVIS-joint facilitates accurate positioning of TKA implants, relative to these alignment axes. The CUVIS-joint is compatible with the following Knee Implant Systems: -United U2 Knee System

Intended Use

The CUVIS-joint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA). The CUVIS-joint is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made. The CUVIS-joint is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The CUVIS-joint facilitates accurate positioning of TKA implants, relative to these alignment axes. The CUVIS-joint is compatible with the following Knee Implant Systems: -United U2 Knee System

Device Description

The CUVIS-joint includes a three-dimensional preoperative planning workstation that uses CT images to create a 3D model of the bone, along with a library of FDA cleared components used to develop implant size and location. The system features user controls including a keyboard, mouse, and a pendant with a mechanically latched Stop Button, as well as an optional foot switch for collecting registration points. The surgical plan data consists of a high level operative plan based on the preoperative plan with a predetermined control file developed to control the robotic arm. The system allows for pre-operative and intraoperative plan adjustments to the translation, rotation, and size of the TKA components to support gap balancing.

Summary parsed at:2026-06-19 04:30:02 UTC

Predicate devices

2

K252037 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K252037 as a predicate