510(k) · Cleared
ClearedSambaScrew 3D 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 Apr 30, 2019 as substantially equivalent to K121148 (Medical Design, LLC, 2012) and 3 other predicates after a 148-day review. Its family tree reaches back 14 generations to 1993. 31 later devices descend from it.
- Decided
- Apr 30, 2019
- Review
- 148 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K930834 (1993). 34 ancestors in all, the oldest K903810 (1990). 31 later devices descend from it, 2 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 backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- This deviceK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- Descendant · cites it directly · 29 of its ownK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 26 of its ownK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- Descendant · 3 generations on · 25 of its ownK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- Descendant · 4 generations on · 19 of its ownK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- Descendant · 5 generations on · 15 of its ownK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 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 backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- This deviceK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K200696FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · cites it directly29descendants
- K201664FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · 2 generations on26descendants
- K203138FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · 3 generations on25descendants
- K210667FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021 · 4 generations on19descendants
- K213667iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022 · 5 generations on15descendants
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 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| 0 (this device) | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| +1 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| +2 | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| +3 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| +4 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
| +5 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 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 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 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? (4)
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 |
|---|---|---|---|
| * | K121148 | Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Summary page 4…e Product Code: OUR Regulatory Classification: Class II – 21 CFR § 888.3040 Review Panel: Orthopedic Device Panel Primary Predicate Device: K121148 – SAMBA Screw System – Orthofix Inc. Additional Predicate Devices: K151818 – Simmetry Sacroiliac Joint Fusion… | 2012 |
| * | K151818 | SImmetry Sacroiliac Joint Fusion SystemSummary page 4…view Panel: Orthopedic Device Panel Primary Predicate Device: K121148 – SAMBA Screw System – Orthofix Inc. Additional Predicate Devices: K151818 – Simmetry Sacroiliac Joint Fusion System – Zyga Technology, Inc. K182983… | 2015 |
| * | K182983 | iFuse Implant System®Summary page 4…nal Predicate Devices: K151818 – Simmetry Sacroiliac Joint Fusion System – Zyga Technology, Inc. K182983 – iFuse Implant System – SI-Bone, Inc. Reference Devices: K172437 – CONSTRUX Mini PEEK Ti Spacer System – Orthofix… | 2018 |
| * | K162733 | iFuse Implant System® - iFuse-3D implantSummary page 5…and the same principles of operation as the predicate SAMBA Screw System (K121148), the SImmentry Sacroiliac Joint Fusion System (K151818) and the iFuse Implant System (K162733). | 2017 |
| † | K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System | 2017 |
What descends from it? (31)
See all 312 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 4 of the 34 ancestors have a recall of any class.
- Of its descendants, K200696 (Orthofix, Inc., 2020) has gone furthest, with 29 descendants of its own.
- 3 other devices also cite its predicate K121148.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 SambaScrew 3D 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/K183342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183342: SambaScrew 3D 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/K183342
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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