510(k) · Cleared
ClearedSilex Sacroiliac Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Mar 11, 2013 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 2 other predicates after a 98-day review. Its family tree reaches back 3 generations to 1990. 49 later devices descend from it.
- Decided
- Mar 11, 2013
- Review
- 98 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K903810 (1990). 7 ancestors in all. 49 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 2 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 1 generation backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- This deviceK123702 Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc. · 2013
- Descendant · cites it directly · 22 of its ownK191748 Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019
- Descendant · 2 generations on · 17 of its ownK203247 iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 15 of its ownK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 3 generations on · 14 of its ownK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · cites it directly · 13 of its ownK153656 PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2016
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019 · cites it directly22descendants
- K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · 2 generations on17descendants
- K213667iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022 · 3 generations on15descendants
- K222605iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022 · 3 generations on14descendants
- K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2016 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −2 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −1 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| 0 (this device) | K123702 | Silex Sacroiliac Joint Fusion System | X-Spine Systems, Inc. | 2013 | — |
| +1 | K191748 | Genesys Spine Sacroiliac Joint Fusion System | Genesys Spine | 2019 | — |
| +2 | K203247 | iFuse-TORQ™ Implant System | SI-BONE, Inc. | 2021 | 1 |
| +3 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +3 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +1 | K153656 | PathLoc-SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2016 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 15 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 2…ical Approach *Anatomical Region *Implant Materials * Product Dimensions * Mechanical Performance PREDICATE DEVICES *Synthes (USA) - 6.5mm Cannulated Screw (K021932) *Zyga Technology, Inc. - Slmmetry Sacroilliac Joint Fusion System (K102907) *SI-Bone, Inc. - SI Joint Fusion System (K0923… | 2002 |
| * | K102907 | Simmetry Sacroiliac Joint Fusion SystemSummary page 2…* Mechanical Performance PREDICATE DEVICES *Synthes (USA) - 6.5mm Cannulated Screw (K021932) *Zyga Technology, Inc. - Slmmetry Sacroilliac Joint Fusion System (K102907) *SI-Bone, Inc. - SI Joint Fusion System (K092375) PERFORMANCE DATA The implant components were tested using the following… | 2010 |
| * | K092375 | Modification to SI Joint Fusion SystemSummary page 2…nthes (USA) - 6.5mm Cannulated Screw (K021932) *Zyga Technology, Inc. - Slmmetry Sacroilliac Joint Fusion System (K102907) *SI-Bone, Inc. - SI Joint Fusion System (K092375) PERFORMANCE DATA The implant components were tested using the following standards: ASTM F543 - Standard Specification and Te… | 2009 |
What descends from it? (49)
See all 496 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191748 | Genesys Spine Sacroiliac Joint Fusion System | 2019 | 22 |
| K153656 | PathLoc-SI Joint Fusion System | 2016 | 13 |
| K140079 | Silex Sacroiliac Joint Fusion System | 2014 | 12 |
| K141106 | Frontier Devices Fusio Screw Fuze System | 2014 | 3 |
| K162121 | Siconus SI Joint Fixation System | 2017 | 1 |
| K170475 | SICAGE™ System | 2017 | 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 23 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K191748 (Genesys Spine, 2019) has gone furthest, with 22 descendants 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. 2013, 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 Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the
pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123702: Silex 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/K123702
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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