510(k) · Cleared
ClearedCaduceus S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Main Orthopaedic Biotechnology Co., Ltd. · SBF Orthopedic Augmented Reality
Cleared on Oct 30, 2024 as substantially equivalent to K183605 (Brainlab AG, 2019) after a 90-day review. Its family tree reaches back 7 generations to 1999. 1 of the 13 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 30, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K983831 (1999). 12 ancestors in all, the oldest K981508 (1998). No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 6 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 5 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 4 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 3 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 2 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 1 generation backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- This deviceK242271 Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd. · 2024
Class I recalls in this family
- K070106 VV Fluoro 3D3 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −6 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −5 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −4 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −3 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −2 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −1 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| 0 (this device) | K242271 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SBF device
- #1 K193559 NextAR TKA Platformscore 20.4 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183605 | Spine & Trauma NavigationSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K183605 11 Spine & Trauma Navigation… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K183605.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SBF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SBF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SBF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · SBF
1in 2025
MAUDE reports naming product code SBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 162 | 0 | 0 |
| 2022 | 7 | 234 | 0 | 0 |
| 2023 | 7 | 104 | 0 | 0 |
| 2024 | 6 | 89 | 0 | 0 |
| 2025 | 13 | 90 | 1 | 1 |
| 2026 | 3 | 123 | 1 | — |
What is it indicated for?
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…
Read the full statement (137 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242271: Caduceus S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242271
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026