Manufacturer
Point Robotics MedTech, Inc.POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
Country / Region:Taiwan (TW)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
- K252755
- Device name
- POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
- Company
- Point Robotics MedTech, Inc.
- Country / Region
- Taiwan(TW)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-08-29
- Decision date
- 2026-01-23
- Submission type
- Traditional
- Technology type
- Robotic Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
"POINT" Kinguide Agile Robotic Arm Surgical Stereotactic System (Kinguide RobotArm) is an accessory to the compatible "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images. The medical indications for use of the CIRQ Robotic Alignment Module for spinal use is the treatment of diseases where the placement of spinal screws is indicated.
Intended Use
"POINT" Kinguide Agile Robotic Arm Surgical Stereotactic System (Kinguide RobotArm) is an accessory to the compatible "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.
Device Description
"POINT" Kinguide Agile Robotic Arm Surgical Stereotactic System (Kinguide RobotArm) is an accessory to the compatible "POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments. Kinguide Agile system is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Kinguide RobotArm is compatible with Kinguide Agile Software version 15.0.0 or above.
Summary parsed at:2026-06-19 04:30:09 UTC
Predicate devices
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Not ingested
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Not ingested
“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
K252755 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252755 as a predicate