510(k) · Cleared
ClearedFirebird SI Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix US, LLC · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 31, 2025 as substantially equivalent to K172517 (SeaSpine Orthopedics Corporation, 2018) and 2 other predicates after a 121-day review. Its family tree reaches back 20 generations to 1993. 2 of the 387 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Oct 31, 2025
- Review
- 121 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K930834 (1993). 385 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 2 of the 387 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK930834 AcutractAcu Med, Inc. · 1993
- 16 generations between
- 3 generations backK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 2 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 1 generation backK211710 Ascent POCT System, Centurion POCT System, Spinal Fixation System…Orthofix, Inc. · 2021
- This deviceK252088 Firebird SI Navigation SystemOrthofix US, LLC · 2025
- Descendant · cites it directly · 0 of its ownK260571 SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026
Show all 20 generations
- Root · 20 generations backK930834 AcutractAcu Med, Inc. · 1993
- 19 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 18 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 17 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 16 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 15 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 14 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 13 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 12 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 11 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 10 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 9 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 8 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 7 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 6 generations backK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- 5 generations backK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- 4 generations backK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 3 generations backK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 2 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 1 generation backK211710 Ascent POCT System, Centurion POCT System, Spinal Fixation System…Orthofix, Inc. · 2021
- This deviceK252088 Firebird SI Navigation SystemOrthofix US, LLC · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −19 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −18 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −17 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −16 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −15 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −14 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −13 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −12 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −11 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −10 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −9 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −8 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −7 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −6 | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| −5 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| −4 | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −3 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −2 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
| −1 | K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS)… | Orthofix, Inc. | 2021 | — |
| 0 (this device) | K252088 | Firebird SI Navigation System | Orthofix US, LLC | 2025 | — |
| +1 | K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 11 | 0 |
| 1997 | 13 | 0 |
| 1998 | 19 | 0 |
| 1999 | 12 | 0 |
| 2000 | 24 | 0 |
| 2001 | 27 | 0 |
| 2002 | 24 | 0 |
| 2003 | 20 | 0 |
| 2004 | 34 | 0 |
| 2005 | 26 | 0 |
| 2006 | 17 | 0 |
| 2007 | 5 | 0 |
| 2008 | 18 | 0 |
| 2009 | 7 | 0 |
| 2010 | 11 | 0 |
| 2011 | 14 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 11 | 1 |
| 2016 | 6 | 1 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K172517 | SeaSpine Navigation SystemSummary page 5…Manufacturer Number Code(s) Primary Predicate SeaSpine Navigation SeaSpine Orthopedics K172517 OLO System Corporation Additional Predicate Device(… | 2018 |
| * | K201189 | Stealthstation S8 Spine Software v1.3.0Summary page 5…System Corporation Additional Predicate Device(s) StealthStation S8 Spine K201189 OLO Medtronic Navigation, Inc. Software… | 2020 |
| * | K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Summary page 5…Medtronic Navigation, Inc. Software v1.3.0 Firebird SI Fusion K211710 OUR Orthofix, Inc. System D… | 2021 |
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 |
|---|---|---|---|
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | 2026 | 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 32 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 57 of the 385 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K260571 (Life Spine, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K172517.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which…
Read the full statement (107 words)
The Firebird SI Navigation System instruments are intended to be used during the preparation and placement of Orthofix Firebird SI Fusion System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Firebird SI Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which 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 a vertebra or pelvis can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252088: Firebird SI Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252088
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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