510(k) · Cleared
ClearedTRELLIS™ SI Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofundamentals, LLC · OUR Sacroiliac Joint Fixation
Cleared on Apr 11, 2022 as substantially equivalent to K203138 (Orthofix, Inc., 2020) and 4 other predicates after a 207-day review. Its family tree reaches back 20 generations to 2004. 1 of the 615 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 11, 2022
- Review
- 207 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 20 generations to K040583 (2004). 614 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet. 1 of the 615 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- 2 generations backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- 1 generation backK183119 SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments…Globus Medical, Inc. · 2019
- This deviceK212962 TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC · 2022
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 7 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 6 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 5 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 4 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 3 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- 2 generations backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- 1 generation backK183119 SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments…Globus Medical, Inc. · 2019
- This deviceK212962 TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC · 2022
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −7 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −6 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −5 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −4 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −3 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −2 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| −1 | K183119 | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments… | Globus Medical, Inc. | 2019 | — |
| 0 (this device) | K212962 | TRELLIS™ SI Joint Fusion System | Orthofundamentals, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 2 | 0 |
| 1979 | 1 | 0 |
| 1981 | 2 | 0 |
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 3 | 0 |
| 1986 | 4 | 0 |
| 1987 | 5 | 0 |
| 1988 | 3 | 0 |
| 1989 | 10 | 0 |
| 1990 | 9 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 7 | 0 |
| 1994 | 14 | 0 |
| 1995 | 23 | 0 |
| 1996 | 27 | 0 |
| 1997 | 19 | 0 |
| 1998 | 21 | 0 |
| 1999 | 26 | 0 |
| 2000 | 31 | 0 |
| 2001 | 45 | 0 |
| 2002 | 39 | 0 |
| 2003 | 38 | 0 |
| 2004 | 46 | 0 |
| 2005 | 42 | 0 |
| 2006 | 26 | 0 |
| 2007 | 17 | 0 |
| 2008 | 27 | 0 |
| 2009 | 15 | 0 |
| 2010 | 16 | 1 |
| 2011 | 16 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 6 | 0 |
| 2015 | 12 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 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.
1 device in this family has a Class I recall. 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 30.8 · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203138 | FIREBIRD SI Fusion SystemSummary page 4…21 CFR 888.3040 Predicate Device Primary Predicate OrthoFix Firebird SI 510(k) K203138 Additional Predicates Synthes 6.5mm Cannulated Screw 510(k) K0291… | 2020 |
| Kept off the family tree | K029132 | 6.5mm Cannulated Screw Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4…510(k) K203138 Additional Predicates Synthes 6.5mm Cannulated Screw 510(k) K029132 Keystone Dental Genesis Implant System 510(k) K101545 SI Bone… | |
| * | K101545 | Genesis Implant SystemSummary page 4…Cannulated Screw 510(k) K029132 Keystone Dental Genesis Implant System 510(k) K101545 SI Bone iFuse Implant System 510(k) K193524 Globus… | 2010 |
| * | K193524 | SI-BONE iFuse Implant System®Summary page 4…sis Implant System 510(k) K101545 SI Bone iFuse Implant System 510(k) K193524 Globus SI-LOK Sacroiliac Joint Fixation System 510(k) K183119 Zyg… | 2020 |
| * | K183119 | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Summary page 4…System 510(k) K193524 Globus SI-LOK Sacroiliac Joint Fixation System 510(k) K183119 Zyga Technology, Inc SImmetry Sacroiliac Joint Fusion System 510(k) K141549 === Page 5 =… | 2019 |
| * | K141549 | SImmetry Sacroiliac Joint Fusion SystemSummary page 4…tion System 510(k) K183119 Zyga Technology, Inc SImmetry Sacroiliac Joint Fusion System 510(k) K141549 K212962… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 83 of the 614 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K203138.
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 OrthoFundamentals TRELLIS™ ST Joint Fusion and Stabilization Implant System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including:
Sacroiliac joint disruptions
Degenerative sacroiliitis
To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
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/K212962 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212962: TRELLIS™ SI Joint Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212962
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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