510(k) · Cleared
Recalled · Class II · 2026iFuse-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 Feb 25, 2021 as substantially equivalent to K193083 (Medacta International S.A., 2019) and 2 other predicates after a 113-day review. Its family tree reaches back 16 generations to 1984. 17 later devices descend from it. It has been recalled once.
- Decided
- Feb 25, 2021
- Review
- 113 days
- Class
- Class II
- Product code
- OUR
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 16 generations to K841189 (1984). 138 ancestors in all. 17 later devices descend from it, 4 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
- 1 generation backK191748 Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019
- This deviceK203247 iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021
- Descendant · cites it directly · 15 of its ownK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · cites it directly · 14 of its ownK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 2 generations on · 5 of its ownK231689 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023
- Descendant · 2 generations on · 4 of its ownK241574 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK223708 Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 6 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 5 generations backK112405 Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 4 generations backK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- 3 generations backK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
- 1 generation backK191748 Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019
- This deviceK203247 iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K213667iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022 · cites it directly15descendants
- K222605iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022 · cites it directly14descendants
- K231689iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023 · 2 generations on5descendants
- K241574iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024 · 2 generations on4descendants
- K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −6 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −5 | K112405 | Clydesdales Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −4 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
| −3 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2016 | — |
| −1 | K191748 | Genesys Spine Sacroiliac Joint Fusion System | Genesys Spine | 2019 | — |
| 0 (this device) | K203247 | iFuse-TORQ™ Implant System | SI-BONE, Inc. | 2021 | — |
| +1 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +1 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +2 | K231689 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2023 | — |
| +2 | K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2024 | — |
| +2 | K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 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 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 8 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K193083 | M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemSummary page 5…Primary Predicate Device Manufacturer 510(k)# Clearance Date M.U.S.T. Sacral Iliac Screw and K193083 December 3, 2019 Medacta International SA Pelvic Trauma System Addit… | 2019 |
| * | K193524 | SI-BONE iFuse Implant System®Summary page 5…Additional Predicate Devices Manufacturer 510(k)# Clearance Date K193524 March 31, 2020 iFuse-3D Implant System SI-BONE, Inc. Genesys Spine Sacroiliac Joint… | 2020 |
| * | K191748 | Genesys Spine Sacroiliac Joint Fusion SystemSummary page 5…2020 iFuse-3D Implant System SI-BONE, Inc. Genesys Spine Sacroiliac Joint Genesys Spine K191748 September 26, 2019 Fusion System… | 2019 |
What descends from it? (17)
See all 174 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2026 | Class II | Z-0146-2027 | Packaging | The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 12 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 138 ancestors have a recall of any class.
- Of its descendants, K213667 (SI-BONE, Inc., 2022) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K193083.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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:
• Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative
sacroiliitis.
• Fracture fixation of small and large bones of the pelvis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203247: iFuse-TORQ™ Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203247
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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