# K220554: Caduceus S

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Main Orthopaedic Biotechnology Co., Ltd.
- Decided: Dec 16, 2022 after 291 days
- Product code: SBF (Orthopedic Augmented Reality)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K983831 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183605: Spine & Trauma Navigation, Brainlab AG (2019) Summary page 4.

## Indications for use
Caduceus S is intended as an intraoperative guidance 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.

Source page: https://510kreport.com/device/K220554
Methodology: https://510kreport.com/methodology