510(k) · Cleared
ClearedGenesys Spine Sacroiliac Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesys Spine · OUR Sacroiliac Joint Fixation
Cleared on Sep 26, 2019 as substantially equivalent to K123702 (X-Spine Systems, Inc., 2013) and 5 other predicates after an 87-day review. Its family tree reaches back 15 generations to 1984. 22 later devices descend from it.
- Decided
- Sep 26, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 15 generations to K841189 (1984). 125 ancestors in all. 22 later devices descend from it, 6 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- 2 generations backK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
- This deviceK191748 Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019
- Descendant · cites it directly · 17 of its ownK203247 iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 15 of its ownK213667 iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 2 generations on · 14 of its ownK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 3 generations on · 5 of its ownK231689 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023
- Descendant · 3 generations on · 4 of its ownK241574 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 5 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 4 generations backK112405 Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 3 generations backK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- 2 generations backK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- 1 generation backK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
- This deviceK191748 Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 2019
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc. · 2021 · cites it directly17descendants
- K213667iFuse-TORQ® Implant SystemSI-BONE, Inc. · 2022 · 2 generations on15descendants
- K222605iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022 · 2 generations on14descendants
- K231689iFuse TORQ® Implant SystemSI-BONE, Inc. · 2023 · 3 generations on5descendants
- K241574iFuse TORQ® Implant SystemSI-BONE, Inc. · 2024 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −5 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −4 | K112405 | Clydesdales Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −3 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
| −2 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −1 | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2016 | — |
| 0 (this device) | K191748 | Genesys Spine Sacroiliac Joint Fusion System | Genesys Spine | 2019 | — |
| +1 | K203247 | iFuse-TORQ™ Implant System | SI-BONE, Inc. | 2021 | 1 |
| +2 | K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +2 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +3 | K231689 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2023 | — |
| +3 | K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2024 | — |
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 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 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? (6)
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 4…ices (DHT6B) Legally Marketed Primary Predicate: Silex Sacroiliac Joint Fusion System (unmodified) devices to (X-Spine Systems, Inc. – K123702) Which Substantial Additional Predicates: Equivalence is Claimed:… | 2013 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 4…tional Predicates: Equivalence is Claimed: Synthes 6.5mm Cannulated Screw (Synthes (USA) – K021932) SI Joint Fusion System (SI-Bone, Inc. – K080398 & K0… | 2002 |
| * | K080398 | SI Joint Fusion SystemSummary page 4…thes 6.5mm Cannulated Screw (Synthes (USA) – K021932) SI Joint Fusion System (SI-Bone, Inc. – K080398 & K092375) SImmetry Sacroiliac Joint Fusion System (Z… | 2008 |
| * | K092375 | Modification to SI Joint Fusion SystemSummary page 4…K021932) SI Joint Fusion System (SI-Bone, Inc. – K080398 & K092375) SImmetry Sacroiliac Joint Fusion System (Zyga Techno… | 2009 |
| * | K141549 | SImmetry Sacroiliac Joint Fusion SystemSummary page 4…K092375) SImmetry Sacroiliac Joint Fusion System (Zyga Technology, Inc. – K141549) RIALTO SI Fusion System (Medtronic Sofamor Danek – K… | 2015 |
| * | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Summary page 4…Technology, Inc. – K141549) RIALTO SI Fusion System (Medtronic Sofamor Danek – K161210) DEVICE DESCRIPTION: Genesys Spine’s Sacroiliac Joint Fusion System consists of partially threaded and fully threaded implants d… | 2016 |
What descends from it? (22)
See all 226 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 35 years and passes through 11 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 125 ancestors have a recall of any class.
- Of its descendants, K203247 (SI-BONE, Inc., 2021) has gone furthest, with 17 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. 2019, 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 Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including
degencrative sacroiliitis and sacroiliac joint disruptions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191748: Genesys Spine Sacroiliac Joint Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191748
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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