510(k) · Cleared
ClearediFuse Implant System - iFuse Navigation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SI-BONE, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Nov 9, 2020 as substantially equivalent to K172268 (SI-BONE, Inc., 2017) after a 25-day review. Its family tree reaches back 14 generations to 1993. 1 later device descends from it.
- Decided
- Nov 9, 2020
- Review
- 25 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K930834 (1993). 30 ancestors in all, the oldest K903810 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK930834 AcutractAcu Med, Inc. · 1993
- 10 generations between
- 3 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 2 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 1 generation backK172268 iFuse Implant System- iFuse NavigationSI-BONE, Inc. · 2017
- This deviceK203110 iFuse Implant System - iFuse NavigationSI-BONE, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK220024 ChoiceSpine Navigation SystemChoice Spine, LLC · 2022
Show all 14 generations
- Root · 14 generations backK930834 AcutractAcu Med, Inc. · 1993
- 13 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 12 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 11 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 10 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 9 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 8 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 7 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 6 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 5 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 4 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 3 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 2 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 1 generation backK172268 iFuse Implant System- iFuse NavigationSI-BONE, Inc. · 2017
- This deviceK203110 iFuse Implant System - iFuse NavigationSI-BONE, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K220024ChoiceSpine Navigation SystemChoice Spine, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −13 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −12 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −11 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −10 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −9 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −8 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −7 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −6 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −5 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −4 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −3 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −2 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −1 | K172268 | iFuse Implant System- iFuse Navigation | SI-BONE, Inc. | 2017 | — |
| 0 (this device) | K203110 | iFuse Implant System - iFuse Navigation | SI-BONE, Inc. | 2020 | — |
| +1 | K220024 | ChoiceSpine Navigation System | Choice Spine, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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.
Planning a device in OLO? 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 |
|---|---|---|---|
| * | K172268 | iFuse Implant System- iFuse NavigationSummary page 4…2.4560– Stereotaxic instrument Product Code: OLO IV. PREDICATE DEVICE SI-BONE, Inc., iFuse Implant System - iFuse-Navigation: K172268 V. DEVICE DESCRIPTION iFuse Implant System - iFuse-Navigation Instrument Set is comprised of reusable manual su… | 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 |
|---|---|---|---|
| K220024 | ChoiceSpine Navigation System | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K220024 (Choice Spine, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K172268.
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?
iFuse-Implant System - iFuse-Navigation Instrument Set is intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in iFuse procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203110: iFuse Implant System - iFuse Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203110
Report an extraction error
Are you the manufacturer?
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