510(k) · Cleared
ClearedBlue Topaz Sacroiliac Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus Fusion Systems, LLC · OUR Sacroiliac Joint Fixation
Cleared on Mar 1, 2022 as substantially equivalent to K152237 (Corelink, LLC, 2016) and 2 other predicates after a 109-day review. Its family tree reaches back 9 generations to 1990. 1 later device descends from it.
- Decided
- Mar 1, 2022
- Review
- 109 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K903810 (1990). 31 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 5 generations between
- 3 generations backK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
- 2 generations backK140079 Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc. · 2014
- 1 generation backK152237 The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC · 2016
- This deviceK213590 Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC · 2022
- Descendant · cites it directly · 0 of its ownK253611 Falco Fusion SystemMcnicoll Surgical, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 8 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 7 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- 6 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 5 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 4 generations backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
- 3 generations backK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
- 2 generations backK140079 Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc. · 2014
- 1 generation backK152237 The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC · 2016
- This deviceK213590 Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K253611Falco Fusion SystemMcnicoll Surgical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −8 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −7 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| −6 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −5 | K111801 | Simmetry (TM) Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −4 | K112028 | SI-Lok Sacroiliac Joint Fixation System | Globus Medical, Inc. | 2011 | — |
| −3 | K110472 | SI-Fix Sacroiliac Joint Fusion System | Medtronic Sofamor Danek | 2012 | — |
| −2 | K140079 | Silex Sacroiliac Joint Fusion System | X-Spine Systems, Inc. | 2014 | — |
| −1 | K152237 | The Entasis Dual-Lead Sacroiliac Implant | Corelink, LLC | 2016 | — |
| 0 (this device) | K213590 | Blue Topaz Sacroiliac Screw System | Osseus Fusion Systems, LLC | 2022 | — |
| +1 | K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | 2026 | — |
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 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K152237 | The Entasis Dual-Lead Sacroiliac ImplantSummary page 5…K213590 - Page 2 of 2 Predicate Devices 510k # Trade or Proprietary or Model Name Manufacturer Product Code Type K152237 Entasis™ Dual-Lead Sacroiliac Implant CoreLink, LLC OUR Primary K181881 Outlet Sacroiliac Joint… | 2016 |
| * | K181881 | Outlet Sacroiliac Joint Fusion SystemSummary page 5…ary or Model Name Manufacturer Product Code Type K152237 Entasis™ Dual-Lead Sacroiliac Implant CoreLink, LLC OUR Primary K181881 Outlet Sacroiliac Joint Fusion System SIJ Surgical OUR Additional K121148 SAMBA™ Screw System… | 2018 |
| * | K121148 | Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Summary page 5…oiliac Implant CoreLink, LLC OUR Primary K181881 Outlet Sacroiliac Joint Fusion System SIJ Surgical OUR Additional K121148 SAMBA™ Screw System Medical Designs LLC HWC, OUR Additional PERFORMANCE DATA The Blue Topaz S… | 2012 |
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 |
|---|---|---|---|
| K253611 | Falco Fusion System | 2026 | 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 32 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 31 ancestors have a recall of any class.
- Of its descendants, K253611 (Mcnicoll Surgical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K152237.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Blue Topaz Sacroiliac Screw 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/K213590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213590: Blue Topaz Sacroiliac Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213590
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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