510(k) · Cleared
ClearedNADIA SI Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ilion Medical, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Aug 5, 2020 as substantially equivalent to K180818 (Tenon Medical, Inc., 2018) and 3 other predicates after a 518-day review. Its family tree reaches back 16 generations to 1984. 3 later devices descend from it.
- Decided
- Aug 5, 2020
- Review
- 518 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K841189 (1984). 123 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
- 1 generation backK180818 Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc. · 2018
- This deviceK190580 NADIA SI Fusion SystemIlion Medical, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK232259 Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC · 2024
- Descendant · cites it directly · 0 of its ownK250894 Eminent Spine Posterior SI SystemEminent Spine · 2025
- Descendant · 2 generations on · 0 of its ownK250001 Patriot SI Implant SystemSpinal Simplicity, LLC · 2025
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 5 generations backK112405 Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 4 generations backK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- 3 generations backK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
- 1 generation backK180818 Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc. · 2018
- This deviceK190580 NADIA SI Fusion SystemIlion Medical, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −5 | K112405 | Clydesdales Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −4 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
| −3 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2016 | — |
| −1 | K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | Tenon Medical, Inc. | 2018 | — |
| 0 (this device) | K190580 | NADIA SI Fusion System | Ilion Medical, Inc. | 2020 | — |
| +1 | K232259 | Patriot-SI Posterior Implant System | Spinal Simplicity, LLC | 2024 | — |
| +1 | K250894 | Eminent Spine Posterior SI System | Eminent Spine | 2025 | — |
| +2 | K250001 | Patriot SI Implant System | Spinal Simplicity, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Summary page 4…Number 888.3040 Classification Panel: Orthopedic Product Code OUR Predicate Device (Primary): Tenon Medical – Catamaran (K180818) Predicate Device (Additional): Globus – SI-LOK (K112028) Medtronic – RIALTO (K161210)… | 2018 |
| * | K112028 | SI-Lok Sacroiliac Joint Fixation SystemSummary page 4…Orthopedic Product Code OUR Predicate Device (Primary): Tenon Medical – Catamaran (K180818) Predicate Device (Additional): Globus – SI-LOK (K112028) Medtronic – RIALTO (K161210) Synthes Cannulated Screw (K021932) P… | 2011 |
| * | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Summary page 4…te Device (Primary): Tenon Medical – Catamaran (K180818) Predicate Device (Additional): Globus – SI-LOK (K112028) Medtronic – RIALTO (K161210) Synthes Cannulated Screw (K021932) Product Description: The NADIA SI Fusion System is LQW… | 2016 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 4…icate Device (Additional): Globus – SI-LOK (K112028) Medtronic – RIALTO (K161210) Synthes Cannulated Screw (K021932) Product Description: The NADIA SI Fusion System is LQWHQGHGWRSURYLGHVXSSRUWDQGVWUXFWXUDOVWDELOLW\GXULQJ sac… | 2002 |
What descends from it? (3)
2 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 36 years and passes through 12 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 123 ancestors have a recall of any class.
- Of its descendants, K232259 (Spinal Simplicity, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K180818.
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 NADIA SI Fusion System is 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/K190580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190580: NADIA SI Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190580
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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