510(k) · Cleared
ClearedOutlet Sacroiliac Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sij Surgical · OUR Sacroiliac Joint Fixation
Cleared on Oct 3, 2018 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 3 other predicates after an 82-day review. Its family tree reaches back 7 generations to 1990. 4 later devices descend from it.
- Decided
- Oct 3, 2018
- Review
- 82 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K903810 (1990). 23 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 6 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 5 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- 4 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 3 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 2 generations backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
- 1 generation backK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
- This deviceK181881 Outlet Sacroiliac Joint Fusion SystemSij Surgical · 2018
- Descendant · cites it directly · 1 of its ownK214123 T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC · 2022
- Descendant · cites it directly · 1 of its ownK213590 Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC · 2022
- Descendant · cites it directly · 0 of its ownK253611 Falco Fusion SystemMcnicoll Surgical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK230689 T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC · 2023
Most influential descendants
Showing 4 of 4 · See all- K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC · 2022 · cites it directly1descendant
- K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC · 2022 · cites it directly1descendant
- K253611Falco Fusion SystemMcnicoll Surgical, Inc. · 2026 · cites it directly0descendants
- K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −6 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −5 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| −4 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −3 | K111801 | Simmetry (TM) Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −2 | K112028 | SI-Lok Sacroiliac Joint Fixation System | Globus Medical, Inc. | 2011 | — |
| −1 | K110472 | SI-Fix Sacroiliac Joint Fusion System | Medtronic Sofamor Danek | 2012 | — |
| 0 (this device) | K181881 | Outlet Sacroiliac Joint Fusion System | Sij Surgical | 2018 | — |
| +1 | K214123 | T-FIX® 3DSI Joint Fusion System | Cutting Edge Spine, LLC | 2022 | — |
| +1 | K213590 | Blue Topaz Sacroiliac Screw System | Osseus Fusion Systems, LLC | 2022 | — |
| +1 | K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | 2026 | — |
| +2 | K230689 | T-FIX™ 3DSI Joint Fusion System | Cutting Edge Spine, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 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.
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 |
|---|---|---|---|
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K021932 6.5mm Cannulated Screw Synthes Primary K110472 MSB Sacroilia… | 2002 |
| * | K110472 | SI-Fix Sacroiliac Joint Fusion SystemSummary page 5…Model Name Type K021932 6.5mm Cannulated Screw Synthes Primary K110472 MSB Sacroiliac Joint Fusion Medtronic Sofamor Additional System… | 2012 |
| * | K112028 | SI-Lok Sacroiliac Joint Fixation SystemSummary page 5…10472 MSB Sacroiliac Joint Fusion Medtronic Sofamor Additional System Danek, Inc K112028 SI-LOK Sacroiliac Joint Globus Medical, Additional Fixation S… | 2011 |
| * | K141549 | SImmetry Sacroiliac Joint Fusion SystemSummary page 5…Inc K112028 SI-LOK Sacroiliac Joint Globus Medical, Additional Fixation System Inc K141549 SImmetry Sacroiliac Joint Zyga Technology, Additional Fusion Sys… | 2015 |
What descends from it? (4)
3 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 28 years and passes through 6 companies; a new generation was cleared every 6 months on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K214123 (Cutting Edge Spine, LLC, 2022) has gone furthest, with 1 descendant of its own.
- 61 other devices also cite its predicate K021932.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Outlet Sacroiliac Joint Fusion System is 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/K181881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181881: Outlet 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/K181881
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