510(k) · Cleared
ClearedHarvester SI: Sacroiliac Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinus International, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Mar 23, 2021 as substantially equivalent to K152237 (Corelink, LLC, 2016) and 4 other predicates after an 85-day review. Its family tree reaches back 17 generations to 1993.
- Decided
- Mar 23, 2021
- Review
- 85 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K930834 (1993). 143 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 17 generations backK930834 AcutractAcu Med, Inc. · 1993
- 13 generations between
- 3 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- 2 generations backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- 1 generation backK201538 Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2020
- This deviceK203780 Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc. · 2021
Show all 17 generations
- Root · 17 generations backK930834 AcutractAcu Med, Inc. · 1993
- 16 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 15 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 14 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 13 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 12 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 11 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 10 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 9 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 8 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 7 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 6 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 5 generations backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- 4 generations backK182983 iFuse Implant System®SI-BONE, Inc. · 2018
- 3 generations backK190230 iFuse Implant System®SI-BONE, Inc. · 2019
- 2 generations backK193524 SI-BONE iFuse Implant System®SI-BONE, Inc. · 2020
- 1 generation backK201538 Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc. · 2020
- This deviceK203780 Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −16 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −15 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −14 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −13 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −12 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −11 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −10 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −9 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −8 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −7 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −6 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −5 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| −4 | K182983 | iFuse Implant System® | SI-BONE, Inc. | 2018 | — |
| −3 | K190230 | iFuse Implant System® | SI-BONE, Inc. | 2019 | — |
| −2 | K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | 2020 | — |
| −1 | K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | 2020 | — |
| 0 (this device) | K203780 | Harvester SI: Sacroiliac Fixation System | Spinus International, Inc. | 2021 | — |
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 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K152237 | The Entasis Dual-Lead Sacroiliac ImplantSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K152237 Entasis™ Dual-Lead CoreLink Primary Sacroiliac Imp… | 2016 |
| * | K121148 | Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM…Summary page 5…Type K152237 Entasis™ Dual-Lead CoreLink Primary Sacroiliac Implant K121148 SAMBA™ Screw System Medical Designs LLC Additional K183342 SambaScrew… | 2012 |
| * | K183342 | SambaScrew 3D SI Fusion SystemSummary page 5…Primary Sacroiliac Implant K121148 SAMBA™ Screw System Medical Designs LLC Additional K183342 SambaScrew 3D SI Fusion Orthofix Inc. Additional System K20… | 2019 |
| * | K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation SystemSummary page 5…dical Designs LLC Additional K183342 SambaScrew 3D SI Fusion Orthofix Inc. Additional System K201538 Life Spine SIMPACT Life Spine Inc. Additional Sacroiliac… | 2020 |
| * | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Summary page 5…Life Spine SIMPACT Life Spine Inc. Additional Sacroiliac Joint Fixation System K161210 Rialto™ SI Fusion System Medtronic Sofamor Additional… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 19 of the 143 ancestors have a recall of any class.
- 4 other devices also cite its predicate K152237.
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 Harvester SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. This includes conditions 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/K203780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203780: Harvester SI: Sacroiliac Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203780
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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