510(k) · Cleared
ClearedEntasis 3D Dual-Lead Sacroiliac Implant System
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 Mar 21, 2023 as substantially equivalent to K212903 (Life Spine, Inc., 2021) and 3 other predicates after a 99-day review. Its family tree reaches back 21 generations to 1993. 3 later devices descend from it.
- Decided
- Mar 21, 2023
- Review
- 99 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K930834 (1993). 220 ancestors in all, the oldest K841189 (1984). 3 later devices descend from it, 2 citing it directly.
- Root · 21 generations backK930834 AcutractAcu Med, Inc. · 1993
- 17 generations between
- 3 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 2 generations backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- 1 generation backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- This deviceK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
- Descendant · cites it directly · 1 of its ownK240505 Eminent Spine SI Screw SystemEminent Spine, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK250894 Eminent Spine Posterior SI SystemEminent Spine · 2025
- Descendant · cites it directly · 0 of its ownK232605 Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES…Lesspine Innovations · 2023
Show all 21 generations
- Root · 21 generations backK930834 AcutractAcu Med, Inc. · 1993
- 20 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 19 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 18 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 17 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 16 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 15 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 14 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 13 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 12 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 11 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 10 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 9 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 8 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 7 generations backK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- 6 generations backK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- 5 generations backK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 4 generations backK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 3 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 2 generations backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- 1 generation backK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- This deviceK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
Most influential descendants
Showing 3 of 3 · See all- K240505Eminent Spine SI Screw SystemEminent Spine, LLC · 2024 · cites it directly1descendant
- K250894Eminent Spine Posterior SI SystemEminent Spine · 2025 · 2 generations on0descendants
- K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −20 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −19 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −18 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −17 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −16 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −15 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −14 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −13 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −12 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −11 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −10 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −9 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −8 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −7 | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| −6 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| −5 | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −4 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −3 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
| −2 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| −1 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| 0 (this device) | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023 | — |
| +1 | K240505 | Eminent Spine SI Screw System | Eminent Spine, LLC | 2024 | — |
| +2 | K250894 | Eminent Spine Posterior SI System | Eminent Spine | 2025 | — |
| +1 | K232605 | Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System… | Lesspine Innovations | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 11 | 0 |
| 1996 | 5 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 10 | 0 |
| 2001 | 11 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 12 | 0 |
| 2005 | 13 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K212903 | SIMPACT Sacroiliac Joint Fixation SystemSummary page 5…Page 2 of 2 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Product Code Predicate Type K212903 SIMPACT Sacroiliac Joint Fixation System Life Spine, Inc. OUR, HWC Primary K222605 iFuse TORQ Im… | 2021 |
| * | K222605 | iFuse TORQ® Implant SystemSummary page 5…Manufacturer Product Code Predicate Type K212903 SIMPACT Sacroiliac Joint Fixation System Life Spine, Inc. OUR, HWC Primary K222605 iFuse TORQ Implant System SI-Bone, Inc. OUR, HWC, OLO Additional K152237 Entasis Du… | 2022 |
| * | K152237 | The Entasis Dual-Lead Sacroiliac ImplantSummary page 5…ion System Life Spine, Inc. OUR, HWC Primary K222605 iFuse TORQ Implant System SI-Bone, Inc. OUR, HWC, OLO Additional K152237 Entasis Dual-Lead Sacroiliac Implant System CoreLink, LLC OUR Additional K220195 iFuse Bedr… | 2016 |
| * | K220195 | iFuse Bedrock Granite™ Implant SystemSummary page 5…SI-Bone, Inc. OUR, HWC, OLO Additional K152237 Entasis Dual-Lead Sacroiliac Implant System CoreLink, LLC OUR Additional K220195 iFuse Bedrock Granite Implant System SI-Bone, Inc. OUR, NKB, OLO Additional PERFORMANCE DATA The Entasi… | 2022 |
What descends from it? (3)
2 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 30 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 30 of the 220 ancestors have a recall of any class.
- Of its descendants, K240505 (Eminent Spine, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K212903.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 3D Dual-Lead Sacroiliac Implant System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223708 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223708: Entasis 3D Dual-Lead Sacroiliac Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223708
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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