510(k) · Cleared
ClearedFalco Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mcnicoll Surgical, Inc. · OUR Sacroiliac Joint Fixation
Cleared on Jan 29, 2026 as substantially equivalent to K181881 (Sij Surgical, 2018) and 2 other predicates after a 72-day review. Its family tree reaches back 17 generations to 1993.
- Decided
- Jan 29, 2026
- Review
- 72 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K930834 (1993). 45 ancestors in all, the oldest K903810 (1990). 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 deviceK253611 Falco Fusion SystemMcnicoll Surgical, Inc. · 2026
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 deviceK253611 Falco Fusion SystemMcnicoll Surgical, Inc. · 2026
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) | K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K181881 | Outlet Sacroiliac Joint Fusion SystemSummary page 5…Sacroiliac Joint Fusion System Classification: OUR, CFR 888.3040, Class II Primary Predicate: Outlet Sacroiliac Joint Fusion System (K181881) Additional Predicates: Blue Topaz Sacroiliac Screw System (K213590) Life Spine SIMPACT Sacr… | 2018 |
| * | K213590 | Blue Topaz Sacroiliac Screw SystemSummary page 5…R, CFR 888.3040, Class II Primary Predicate: Outlet Sacroiliac Joint Fusion System (K181881) Additional Predicates: Blue Topaz Sacroiliac Screw System (K213590) Life Spine SIMPACT Sacroiliac Joint Fixation System (K201538) Device Description: The Falco Fus… | 2022 |
| * | K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation SystemSummary page 5…m (K181881) Additional Predicates: Blue Topaz Sacroiliac Screw System (K213590) Life Spine SIMPACT Sacroiliac Joint Fixation System (K201538) Device Description: The Falco Fusion System is designed to stabilize or fuse the sacroiliac (SI) joint, helping to reduce pai… | 2020 |
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 33 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 4 of the 45 ancestors have a recall of any class.
- 2 other devices also cite its predicate K181881.
How does its category compare?
All OUR devicesOUR Sacroiliac Joint Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Falco Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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/K253611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253611: Falco Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253611
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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