Manufacturer
Point Robotics MedTech, Inc.“POINT” Kinguide Agile Hybrid Navigation System
Country / Region:Taiwan (TW)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Device details
FDA 510(k) registration fields
- K number
- K230087
- Device name
- “POINT” Kinguide Agile Hybrid Navigation 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
- 2023-01-12
- Decision date
- 2023-07-17
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation SystemOther
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images. The indications include all medical procedures in which pedicle screws are implanted posteriorly into lumbar vertebrae (L1-L5) or sacral vertebrae (S1). This can include, but is not limited to, the following procedures: • Pedicle Screw Placement • Iliosacral Screw Placement • Interbody Device Placement
Intended Use
"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.
Device Description
"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an image-guided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT). The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking.
Summary parsed at:2026-06-19 05:43:41 UTC
Predicate devices
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Not ingested
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Not ingested
“POINT” Kinguide Robotic-Assisted Surgical System
K230087 references 3 predicate/reference devices
Cited as predicate
1“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
1 submission cite K230087 as a predicate
