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 25, 2014 as substantially equivalent to K123702 (X-Spine Systems, Inc., 2013) and 4 other predicates after a 71-day review. Its family tree reaches back 7 generations to 1990. 12 later devices descend from it.
- Decided
- Mar 25, 2014
- Review
- 71 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K903810 (1990). 26 ancestors in all. 12 later devices descend from it, 1 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 deviceK140079 Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc. · 2014
- Descendant · cites it directly · 11 of its ownK152237 The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
- Descendant · 2 generations on · 2 of its ownK223521 ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK240505 Eminent Spine SI Screw SystemEminent Spine, LLC · 2024
- Descendant · 3 generations on · 1 of its ownK231841 PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC · 2016 · cites it directly11descendants
- K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023 · 2 generations on3descendants
- K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023 · 2 generations on2descendants
- K240505Eminent Spine SI Screw SystemEminent Spine, LLC · 2024 · 3 generations on1descendant
- K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2023 · 3 generations on1descendant
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) | K140079 | Silex Sacroiliac Joint Fusion System | X-Spine Systems, Inc. | 2014 | — |
| +1 | K152237 | The Entasis Dual-Lead Sacroiliac Implant | Corelink, LLC | 2016 | — |
| +2 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023 | — |
| +2 | K223521 | ZESPIN SI Joint Fusion System | Aegis Spine, Inc. | 2023 | — |
| +3 | K240505 | Eminent Spine SI Screw System | Eminent Spine, LLC | 2024 | — |
| +3 | K231841 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 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 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (5)
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 2…The purpose of this submission isto modify the Indications for Use (IFU). PREDICATE DEVICES * X-spine Systems, Inc. - Silex Sacroiliac Joint Fusion System (1<123702) " SI-Bone, Inc. - iFuse Implant System (K<131405) * Zyga Technology, Inc. - Slmmetry Sacroiliac Joint Fusi… | 2013 |
| * | K131405 | Ifuse Implant SystemSummary page 2…or Use (IFU). PREDICATE DEVICES * X-spine Systems, Inc. - Silex Sacroiliac Joint Fusion System (1<123702) " SI-Bone, Inc. - iFuse Implant System (K<131405) * Zyga Technology, Inc. - Slmmetry Sacroiliac Joint Fusion System (K<130092) * Globus Medical, Inc. - Sl-L… | 2013 |
| * | K130092 | Simmetry Sacroiliac Joint Fusion SystemSummary page 2…int Fusion System (1<123702) " SI-Bone, Inc. - iFuse Implant System (K<131405) * Zyga Technology, Inc. - Slmmetry Sacroiliac Joint Fusion System (K<130092) * Globus Medical, Inc. - Sl-LO< Sacroiliac Joint Fixation System (K112028) * Medtronic Sofamor Danek, Inc.… | 2013 |
| * | K112028 | SI-Lok Sacroiliac Joint Fixation SystemSummary page 2…405) * Zyga Technology, Inc. - Slmmetry Sacroiliac Joint Fusion System (K<130092) * Globus Medical, Inc. - Sl-LO< Sacroiliac Joint Fixation System (K112028) * Medtronic Sofamor Danek, Inc. - MSB Sacroiliac Joint Fusion System (K<110472) EQUIVALENCE TO MARKETED PRODUCT X-sp… | 2011 |
| * | K110472 | SI-Fix Sacroiliac Joint Fusion SystemSummary page 2…* Globus Medical, Inc. - Sl-LO< Sacroiliac Joint Fixation System (K112028) * Medtronic Sofamor Danek, Inc. - MSB Sacroiliac Joint Fusion System (K<110472) EQUIVALENCE TO MARKETED PRODUCT X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes, of FDA's… | 2012 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152237 | The Entasis Dual-Lead Sacroiliac Implant | 2016 | 11 |
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 24 years and passes through 6 companies; a new generation was cleared every 6 months on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K152237 (Corelink, LLC, 2016) has gone furthest, with 11 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. 2014, 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 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/K140079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140079: 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/K140079
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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