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510(k) Data Aggregation
K Number
K242271Device Name
Caduceus S
Manufacturer
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
Date Cleared
2024-10-30
(90 days)
Product Code
SBF
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Caduceus S is intended as an aid for precisely locating anatomical structures in percutaneous spine procedures. It is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, when reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT or 2D/3D C-arm images of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and lumbosacral spine. Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments. The Headset of the Caduceus S displays 2D stereotaxic screens and a 3D anatomy model (floating). The displayed stereotaxic screens are indicated for correlating the tracked instrument location to the patient registered imagery to assist in percutaneous visualization and trajectory planning.
Device Description
The Caduceus S system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Navigation Cart, Navi Tracker, Headset, Minimally Invasive Spine Surgery Instruments, Disposable Passive Spheres, and other disposable surgical consumables. It uses optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' eyes using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.
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K Number
K220554Device Name
Caduceus S
Manufacturer
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
Date Cleared
2022-12-16
(291 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Caduceus S is intended as an intraoperative gudance system to enable minimally invasive surgery. Intraoperatively registered surgical Instruments are tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.
Caduceus S enables image-guide navigation of medical image data, which can either be acquired preoperatively CT or intraoperatively C-arm by an appropriate image acquisition system.
Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments.
Caduceus S is indicated for L5~T6 spine surgery where reference to a rigid anatomical structure can be identified relative to the acquired patient imagery (CT or C-arm).
The headset (Surglasses) of the Caduceus S system is an optional heads up display that projects the 2D stereotaxic screens of the system's display.
Device Description
Caduceus S surgical navigation system is an image guidance system, which is composed of Navi Tracker, Surglasses, other hardware (Navigation Cart with an arm, Touch Screen, Router, Control System, Connection System), disposable tools (Disposable Passive Sphere, Straight Guide Pin, Navi Clamp Kit, Instrument Adapter Type A&B, Calibration Plate, Registration Kit, Correction Tool), reusable tools (Calibration Board, Instrument Holder), and Spine Navigation Software. Caduceus S is an optical tracking and guiding system for spine surgery. It can track the marks on the surgical instruments and patient's anatomical structure with marks, and register with the preoperative or intraoperative images of the patients. During the surgery, it can be displayed on the Touch Screen and the head mounted display Surglasses to provide the navigation for the surgical instruments.
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