510(k) · Cleared
ClearedJoimax Intracs System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joimax GmbH · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 30, 2020 as substantially equivalent to K170011 (Medtronic Navigation, 2017) after a 309-day review. Its family tree reaches back 4 generations to 2005. 2 of the 7 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jul 30, 2020
- Review
- 309 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050438 (2005). 5 ancestors in all, the oldest K992927 (1999). 1 later device descends from it, 1 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 3 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 2 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 1 generation backK170011 StealthStation S8 Spine Software v1.0.0Medtronic Navigation · 2017
- This deviceK192663 Joimax Intracs SystemJoimax GmbH · 2020
- Descendant · cites it directly · 0 of its ownK230700 RIWOtrack Navigation SystemFiagon GmbH · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K230700RIWOtrack Navigation SystemFiagon GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −3 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −2 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −1 | K170011 | StealthStation S8 Spine Software v1.0.0 | Medtronic Navigation | 2017 | — |
| 0 (this device) | K192663 | Joimax Intracs System | Joimax GmbH | 2020 | — |
| +1 | K230700 | RIWOtrack Navigation System | Fiagon GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
2 devices in this family have 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K170011 | StealthStation S8 Spine Software v1.0.0Summary page 4…ulatory Class: 2 Regulation Number: 21 CFR 882.4560 Product Code: OLO III. PREDICATE DEVICE StealthStation S8 Spine Software (K170011) IV. DEVICE DESCRIPTION The joimax® Intracs® em System is a surgical navigation system based on… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230700 | RIWOtrack Navigation System | 2023 | 0 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K230700 (Fiagon GmbH, 2023) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K170011.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The joimax® Intracs® em Navigation System is intended to continuously display the position and orientation of joimax® surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures.
The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.
This can include spinal procedures, where the target point for the procedure itself or for the access to the area of interest, is a rigid landmark, such as:
• Transforaminal procedure
• Interlaminar procedure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192663: Joimax Intracs System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192663
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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