510(k) · Cleared
ClearedREUNION Sacroiliac Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical · OUR Sacroiliac Joint Fixation
Cleared on Oct 24, 2023 as substantially equivalent to K161210 (Medtronic Sofamor Danek, 2016) and 1 other predicate after a 90-day review. Its family tree reaches back 15 generations to 1984. 1 later device descends from it.
- Decided
- Oct 24, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K841189 (1984). 126 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- 2 generations backK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
- This deviceK232211 REUNION Sacroiliac Joint Fusion SystemAstura Medical · 2023
- Descendant · cites it directly · 0 of its ownK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 4 generations backK112405 Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- 2 generations backK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
- This deviceK232211 REUNION Sacroiliac Joint Fusion SystemAstura Medical · 2023
Most influential descendants
Showing 1 of 1 · See all- K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −4 | K112405 | Clydesdales Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
| −2 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2016 | — |
| 0 (this device) | K232211 | REUNION Sacroiliac Joint Fusion System | Astura Medical | 2023 | — |
| +1 | K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 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 | 5 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Summary page 5…t Code OUR CFR Section 21 CFR section 888.3040 Device Panel Orthopedic Primary Predicate Device RIALTO SI Fusion System (K161210) Additional Predicate M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K203671) Device Reference Predicate Ol… | 2016 |
| * | K203671 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemSummary page 5…Orthopedic Primary Predicate Device RIALTO SI Fusion System (K161210) Additional Predicate M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System (K203671) Device Reference Predicate Olympic Posterior Spinal Fixation System (K182239) Device Device Description The Reu… | 2021 |
| † | K182239 | OLYMPIC Posterior Spinal Fixation System | 2018 |
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 |
|---|---|---|---|
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | 2025 | 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 39 years and passes through 11 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 126 ancestors have a recall of any class.
- Of its descendants, K252346 (Astura Medical, 2025) has gone furthest, with 0 descendants of its own.
- 26 other devices also cite its predicate K161210.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 REUNION SI Joint System is indicated for skeletally mature patients 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/K232211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232211: REUNION Sacroiliac Joint 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/K232211
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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