510(k) · Cleared
ClearediFuse TORQ® Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SI-BONE, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Sep 29, 2022 as substantially equivalent to K213667 (SI-BONE, Inc., 2022) and 4 other predicates after a 31-day review. Its family tree reaches back 20 generations to 1993. 14 later devices descend from it.
- Decided
- Sep 29, 2022
- Review
- 31 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K930834 (1993). 148 ancestors in all, the oldest K841189 (1984). 14 later devices descend from it, 5 citing it directly.
- Root · 20 generations backK930834 AcutractAcu Med, Inc. · 1993
- 16 generations between
- 3 generations backK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 2 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 1 generation backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- This deviceK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · cites it directly · 5 of its ownK231689 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023
- Descendant · cites it directly · 4 of its ownK241574 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024
- Descendant · cites it directly · 3 of its ownK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
- Descendant · cites it directly · 2 of its ownK231829 Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 2023
- Descendant · 2 generations on · 1 of its ownK243565 DYNAMIS™ SI Screw SystemPromethean Restorative, LLC · 2025
Show all 20 generations
- Root · 20 generations backK930834 AcutractAcu Med, Inc. · 1993
- 19 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 18 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 17 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 16 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 15 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 14 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 13 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 12 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 11 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 10 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 9 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 8 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 7 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 6 generations backK183342 SambaScrew 3D SI Fusion SystemOrthofix, Inc. · 2019
- 5 generations backK200696 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020 · Recalled
- 4 generations backK201664 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 3 generations backK203138 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2020
- 2 generations backK210667 FIREBIRD SI Fusion SystemOrthofix, Inc. · 2021
- 1 generation backK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- This deviceK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K231689iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023 · cites it directly5descendants
- K241574iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024 · cites it directly4descendants
- K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023 · cites it directly3descendants
- K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical · 2023 · cites it directly2descendants
- K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −19 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −18 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −17 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −16 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −15 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −14 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −13 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −12 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −11 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −10 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −9 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −8 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −7 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −6 | K183342 | SambaScrew 3D SI Fusion System | Orthofix, Inc. | 2019 | — |
| −5 | K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | 1 |
| −4 | K201664 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −3 | K203138 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2020 | — |
| −2 | K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | 2021 | — |
| −1 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| 0 (this device) | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +1 | K231689 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2023 | — |
| +1 | K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2024 | — |
| +1 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023 | — |
| +1 | K231829 | Xenix Medical Sacroiliac Fixation System | Ht Medical D.B.A. Xenix Medical | 2023 | — |
| +2 | K243565 | DYNAMIS™ SI Screw System | Promethean Restorative, LLC | 2025 | — |
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 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K213667 | iFuse-TORQ® Implant SystemSummary page 4…Product Code: OUR, HWC and OLO III. PREDICATE AND REFERENCE DEVICES Primary Predicate: iFuse TORQ Implant System K213667 Additional Predicates: iFuse TORQ Implant System K203247 iFuse-3… | 2022 |
| * | K203247 | iFuse-TORQ™ Implant SystemSummary page 4…ND REFERENCE DEVICES Primary Predicate: iFuse TORQ Implant System K213667 Additional Predicates: iFuse TORQ Implant System K203247 iFuse-3D Implant System, K190230, K182983, K172268 IV. DEVICE DESCRIPTION… | 2021 |
| * | K190230 | iFuse Implant System®Summary page 4…Implant System K213667 Additional Predicates: iFuse TORQ Implant System K203247 iFuse-3D Implant System, K190230, K182983, K172268 IV. DEVICE DESCRIPTION The iFuse TORQ Implant System consists of the iFuse-TORQ Implants… | 2019 |
| * | K182983 | iFuse Implant System®Summary page 4…ystem K213667 Additional Predicates: iFuse TORQ Implant System K203247 iFuse-3D Implant System, K190230, K182983, K172268 IV. DEVICE DESCRIPTION The iFuse TORQ Implant System consists of the iFuse-TORQ Implants and assoc… | 2018 |
| * | K172268 | iFuse Implant System- iFuse NavigationSummary page 4…3667 Additional Predicates: iFuse TORQ Implant System K203247 iFuse-3D Implant System, K190230, K182983, K172268 IV. DEVICE DESCRIPTION The iFuse TORQ Implant System consists of the iFuse-TORQ Implants and associated… | 2017 |
What descends from it? (14)
See all 145 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 29 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 21 of the 148 ancestors have a recall of any class.
- Of its descendants, K231689 (SI-BONE, Inc., 2023) has gone furthest, with 5 descendants of its own.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 iFuse TORQ Implant System is indicated for sacroiliac joint fusion for: • Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. • Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute…
Read the full statement (163 words)
The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for:
• Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORQ Navigation instruments are intended to be used with the Medtronic StealthStation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222605 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222605: iFuse TORQ® 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/K222605
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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