510(k) · Cleared
ClearedSiconus SI Joint Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies · OUR Sacroiliac Joint Fixation
Cleared on Jan 18, 2017 as substantially equivalent to K123702 (X-Spine Systems, Inc., 2013) and 2 other predicates after a 170-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Jan 18, 2017
- Review
- 170 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K903810 (1990). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 3 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 2 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- 1 generation backK123702 Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc. · 2013
- This deviceK162121 Siconus SI Joint Fixation SystemCamber Spine Technologies · 2017
- Descendant · cites it directly · 0 of its ownK211785 CASSATT™ SIJ Fixation SystemCtl Medical Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −3 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −2 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| −1 | K123702 | Silex Sacroiliac Joint Fusion System | X-Spine Systems, Inc. | 2013 | — |
| 0 (this device) | K162121 | Siconus SI Joint Fixation System | Camber Spine Technologies | 2017 | — |
| +1 | K211785 | CASSATT™ SIJ Fixation System | Ctl Medical Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K123702 | Silex Sacroiliac Joint Fusion SystemSummary page 4…fication Panel: Orthopedic Product Code OUR Reason for 510(k) New Device Predicate Device Xtant (X-Spine) Silex™ SI Joint Fusion System (K123702) Synthes Cannulated Screw (K021932) Zyga SImmetry Sacroiliac Joint Fusion Sys… | 2013 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 4…Reason for 510(k) New Device Predicate Device Xtant (X-Spine) Silex™ SI Joint Fusion System (K123702) Synthes Cannulated Screw (K021932) Zyga SImmetry Sacroiliac Joint Fusion System (K102907) Indications: The Siconus™ SI Fixation System… | 2002 |
| * | K102907 | Simmetry Sacroiliac Joint Fusion SystemSummary page 4…ex™ SI Joint Fusion System (K123702) Synthes Cannulated Screw (K021932) Zyga SImmetry Sacroiliac Joint Fusion System (K102907) Indications: The Siconus™ SI Fixation System is intended to provide fixation and stabilization of large bones, including the s… | 2010 |
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 |
|---|---|---|---|
| K211785 | CASSATT™ SIJ Fixation System | 2022 | 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 27 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K211785 (Ctl Medical Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K123702.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 SICONUS™ SI Joint Fixation System is intended to provide fixation and stabilization of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of degenerative sacroiliitis, or sacroiliac joint disruptions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162121: Siconus SI Joint Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162121
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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