510(k) · Cleared
ClearedSICAGE™ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sicage, LLC · OUR Sacroiliac Joint Fixation
Cleared on May 5, 2017 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 1 other predicate after a 78-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- May 5, 2017
- Review
- 78 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K903810 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK170475 SICAGE™ SystemSicage, LLC · 2017
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) | K170475 | SICAGE™ System | Sicage, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 5…crews are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). Primary Predicate: Synthes 6.5mm Cannulated Screw (Synthes (USA) – K021932) Additional Predicate: Silex Sacroiliac Joint Fusion System (X-Spine Systems – K123702) Performance Data: Mechanical test… | 2002 |
| * | K123702 | Silex Sacroiliac Joint Fusion SystemSummary page 5…M F136). Primary Predicate: Synthes 6.5mm Cannulated Screw (Synthes (USA) – K021932) Additional Predicate: Silex Sacroiliac Joint Fusion System (X-Spine Systems – K123702) Performance Data: Mechanical testing of worst case SICAGE System screws included torsion and pullo… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 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. 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?
SICAGE 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/K170475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170475: SICAGE™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170475
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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