510(k) · Cleared
ClearedThe Entasis Dual-Lead Sacroiliac Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · OUR Sacroiliac Joint Fixation
Cleared on Feb 4, 2016 as substantially equivalent to K021932 (Synthes (Usa), 2002) and 1 other predicate after a 178-day review. Its family tree reaches back 8 generations to 1990. 11 later devices descend from it.
- Decided
- Feb 4, 2016
- Review
- 178 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K903810 (1990). 27 ancestors in all. 11 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 7 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 6 generations backK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
- 5 generations backK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 4 generations backK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
- 3 generations backK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011
- 2 generations backK110472 SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek · 2012
- 1 generation backK140079 Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc. · 2014
- This deviceK152237 The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC · 2016
- Descendant · cites it directly · 3 of its ownK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
- Descendant · cites it directly · 2 of its ownK223521 ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK240505 Eminent Spine SI Screw SystemEminent Spine, LLC · 2024
- Descendant · 2 generations on · 1 of its ownK231841 PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK213590 Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023 · cites it directly3descendants
- K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc. · 2023 · cites it directly2descendants
- K240505Eminent Spine SI Screw SystemEminent Spine, LLC · 2024 · 2 generations on1descendant
- K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd. · 2023 · 2 generations on1descendant
- K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −7 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −6 | K102907 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2010 | — |
| −5 | K110512 | Simmetry Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −4 | K111801 | Simmetry (TM) Sacroiliac Joint Fusion System | Zyga Technology, Inc. | 2011 | — |
| −3 | K112028 | SI-Lok Sacroiliac Joint Fixation System | Globus Medical, Inc. | 2011 | — |
| −2 | K110472 | SI-Fix Sacroiliac Joint Fusion System | Medtronic Sofamor Danek | 2012 | — |
| −1 | K140079 | Silex Sacroiliac Joint Fusion System | X-Spine Systems, Inc. | 2014 | — |
| 0 (this device) | K152237 | The Entasis Dual-Lead Sacroiliac Implant | Corelink, LLC | 2016 | — |
| +1 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023 | — |
| +1 | K223521 | ZESPIN SI Joint Fusion System | Aegis Spine, Inc. | 2023 | — |
| +2 | K240505 | Eminent Spine SI Screw System | Eminent Spine, LLC | 2024 | — |
| +2 | K231841 | PathLoc SI Joint Fusion System | L&K BIOMED Co., Ltd. | 2023 | — |
| +1 | K213590 | Blue Topaz Sacroiliac Screw System | Osseus Fusion Systems, LLC | 2022 | — |
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 |
|---|---|---|
| 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? (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…Trade or Proprietary or Model Manufacturer Predicate Name Type K021932 6.5mm Cannulated Screw Synthes Primary K140079 Silex… | 2002 |
| * | K140079 | Silex Sacroiliac Joint Fusion SystemSummary page 5…Name Type K021932 6.5mm Cannulated Screw Synthes Primary K140079 Silex X-spine Additional… | 2014 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K223708 (Corelink, LLC, 2023) has gone furthest, with 3 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. 2016, 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 Entasis™ Dual-Lead Sacroiliac Implant system is intended for sacroiliac joint fusion for
conditions including degenerative sacroilitis and sacroiliac joint disruptions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152237: The Entasis Dual-Lead Sacroiliac Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152237
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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