510(k) · Cleared
ClearedFIREBIRD SI Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Sep 15, 2020 as substantially equivalent to K200696 (Orthofix, Inc., 2020) after an 88-day review. Its family tree reaches back 16 generations to 1993. 26 later devices descend from it.
- Decided
- Sep 15, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K930834 (1993). 36 ancestors in all, the oldest K903810 (1990). 26 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK930834 AcutractAcu Med, Inc. · 1993
- 12 generations between
- 3 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 2 generations backK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- 1 generation backK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- This deviceK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- Descendant · cites it directly · 25 of its ownK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- Descendant · 2 generations on · 19 of its ownK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- Descendant · 3 generations on · 15 of its ownK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 4 generations on · 14 of its ownK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 5 generations on · 5 of its ownK231689 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023
Show all 16 generations
- Root · 16 generations backK930834 AcutractAcu Med, Inc. · 1993
- 15 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 14 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 13 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 12 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 11 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 10 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 9 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 8 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 7 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 6 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 5 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 4 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 3 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 2 generations backK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- 1 generation backK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- This deviceK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K203138FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · cites it directly25descendants
- K210667FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021 · 2 generations on19descendants
- K213667iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022 · 3 generations on15descendants
- K222605iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022 · 4 generations on14descendants
- K231689iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −15 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −14 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −13 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −12 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −11 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −10 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −9 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −8 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −7 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −6 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −5 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −4 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −3 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −2 | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| −1 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| 0 (this device) | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| +1 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| +2 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
| +3 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +4 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +5 | K231689 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2023 | — |
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 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 OUR? 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 OUR device
- #1 K233508 iFuse Bedrock Granite® Implant Systemscore 30.7 · 31 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 |
|---|---|---|---|
| * | K200696 | FIREBIRD SI Fusion SystemSummary page 4…§ 888.3040 Smooth or threaded metallic bone fixation fastener Review Panel: Orthopedic Device Panel Primary Predicate: K200696 – Orthofix Inc. – FIREBIRD SI Fusion System Reference Predicate Device: K200052 – Orthofix Inc. – PTC Systems Product Claims Re… | 2020 |
| † | K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System | 2020 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203138 | FIREBIRD SI Fusion System | 2020 | 25 |
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 4 companies; a new generation was cleared every 9 months on median.
- 5 of the 36 ancestors have a recall of any class.
- Of its descendants, K203138 (Orthofix, Inc., 2020) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K200696.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OUR
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OUR
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OUR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUR
10in 2025
MAUDE reports naming product code OUR, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 27 | 0 | 6 |
| 2012 | 2 | — | 0 | 81 |
| 2013 | 4 | 103 | 0 | 96 |
| 2014 | 3 | 91 | 0 | 146 |
| 2015 | 8 | 111 | 0 | 119 |
| 2016 | 6 | 168 | 0 | 122 |
| 2017 | 4 | 120 | 0 | 157 |
| 2018 | 7 | 82 | 0 | 137 |
| 2019 | 7 | 89 | 0 | 175 |
| 2020 | 7 | 88 | 0 | 148 |
| 2021 | 9 | 85 | 0 | 154 |
| 2022 | 14 | 149 | 0 | 23 |
| 2023 | 20 | 55 | 0 | 7 |
| 2024 | 15 | 74 | 0 | 15 |
| 2025 | 14 | 97 | 1 | 10 |
| 2026 | 6 | 98 | 1 | — |
What is it indicated for?
The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201664: FIREBIRD SI Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201664
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