510(k) · Cleared
ClearedCATAMARAN™ SI Joint Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenon Medical · OUR Sacroiliac Joint Fixation
Cleared on Apr 8, 2026 as substantially equivalent to K250403 (Tenon Medical, 2025) and 2 other predicates after a 55-day review. Its family tree reaches back 18 generations to 1984.
- Decided
- Apr 8, 2026
- Review
- 55 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K841189 (1984). 135 ancestors in all. No later device cites it as a predicate yet.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK180818 Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc. · 2018
- 2 generations backK231944 CATAMARAN SI Joint Fusion SystemTenon Medical, Inc. · 2023
- 1 generation backK250403 Catamaran SI Joint Fusion SystemTenon Medical · 2025
- This deviceK260477 CATAMARAN™ SI Joint Fusion SystemTenon Medical · 2026
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK112405 Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK131425 Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale…Medtronic Navigation, Inc. · 2013 · Recalled
- 5 generations backK150231 Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc. · 2015
- 4 generations backK161210 RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2016
- 3 generations backK180818 Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc. · 2018
- 2 generations backK231944 CATAMARAN SI Joint Fusion SystemTenon Medical, Inc. · 2023
- 1 generation backK250403 Catamaran SI Joint Fusion SystemTenon Medical · 2025
- This deviceK260477 CATAMARAN™ SI Joint Fusion SystemTenon Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K112405 | Clydesdales Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K131425 | Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter | Medtronic Navigation, Inc. | 2013 | 10 |
| −5 | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −4 | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2016 | — |
| −3 | K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | Tenon Medical, Inc. | 2018 | — |
| −2 | K231944 | CATAMARAN SI Joint Fusion System | Tenon Medical, Inc. | 2023 | — |
| −1 | K250403 | Catamaran SI Joint Fusion System | Tenon Medical | 2025 | — |
| 0 (this device) | K260477 | CATAMARAN™ SI Joint Fusion System | Tenon Medical | 2026 | — |
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 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K250403 | Catamaran SI Joint Fusion SystemSummary page 5…Sacroiliac Joint Fixation Classification: 21 CFR 888.3040 Product Code: OUR Primary Predicate: CATAMARAN SI Joint Fusion System (K250403) Additional Predicates: CATAMARAN SI Joint Fusion System (K180818) CATAMARAN SI Joint Fusion Sy… | 2025 |
| * | K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Summary page 5…0 Product Code: OUR Primary Predicate: CATAMARAN SI Joint Fusion System (K250403) Additional Predicates: CATAMARAN SI Joint Fusion System (K180818) CATAMARAN SI Joint Fusion System (K231944) Device Description: The CATAMARAN SI Joint Fusion Syste… | 2018 |
| * | K231944 | CATAMARAN SI Joint Fusion SystemSummary page 5…AN SI Joint Fusion System (K250403) Additional Predicates: CATAMARAN SI Joint Fusion System (K180818) CATAMARAN SI Joint Fusion System (K231944) Device Description: The CATAMARAN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacr… | 2023 |
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 42 years and passes through 12 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 135 ancestors have a recall of any class.
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 Tenon Medical Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including:
Sacroiliac joint disruptions and 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.
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/K260477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260477: CATAMARAN™ SI Joint 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/K260477
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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