510(k) · Cleared
ClearedCASSATT™ SIJ Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ctl Medical Corporation · OUR Sacroiliac Joint Fixation
Cleared on Oct 17, 2022 as substantially equivalent to K211449 (Choice Spine, LLC, 2021) and 2 other predicates after a 495-day review. Its family tree reaches back 22 generations to 1984. 1 of the 243 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 17, 2022
- Review
- 495 days
- Class
- Class II
- Product code
- OUR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K841189 (1984). 242 ancestors in all. No later device cites it as a predicate yet. 1 of the 243 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 2 generations backK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- 1 generation backK211449 Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC · 2021
- This deviceK211785 CASSATT™ SIJ Fixation SystemCtl Medical Corporation · 2022
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 12 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 11 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 10 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 9 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 8 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 7 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 6 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 5 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 4 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 3 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 2 generations backK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- 1 generation backK211449 Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC · 2021
- This deviceK211785 CASSATT™ SIJ Fixation SystemCtl Medical Corporation · 2022
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −12 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −11 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −10 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −9 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −8 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −7 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −6 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −5 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −4 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| −3 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| −2 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
| −1 | K211449 | Triton™ Sacroiliac Joint Fixation System | Choice Spine, LLC | 2021 | — |
| 0 (this device) | K211785 | CASSATT™ SIJ Fixation System | Ctl Medical Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 12 | 0 |
| 2002 | 10 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 21 | 0 |
| 2006 | 7 | 0 |
| 2007 | 11 | 0 |
| 2008 | 29 | 1 |
| 2009 | 16 | 0 |
| 2010 | 13 | 0 |
| 2011 | 15 | 0 |
| 2012 | 8 | 0 |
| 2013 | 9 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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.
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 30.7 · 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 |
|---|---|---|---|
| * | K211449 | Triton™ Sacroiliac Joint Fixation System Cleared while this submission was under review Summary page 4…OUR 510(k) summary prepared: October 12, 2022 III. Predicate Devices Triton Sacroiliac Joint Fixation System (Primary Predicate) (K211449) Siconus SI Joint Fixation System (Additional predicate) (K162121) Synthes Cannulated Screws (Additional predicate)… | 2021 |
| * | K162121 | Siconus SI Joint Fixation SystemSummary page 4…2 III. Predicate Devices Triton Sacroiliac Joint Fixation System (Primary Predicate) (K211449) Siconus SI Joint Fixation System (Additional predicate) (K162121) Synthes Cannulated Screws (Additional predicate) (K021932)… | 2017 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 4…on System (Primary Predicate) (K211449) Siconus SI Joint Fixation System (Additional predicate) (K162121) Synthes Cannulated Screws (Additional predicate) (K021932) K211785… | 2002 |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 19 companies; a new generation was cleared every 10 months on median.
- 32 of the 242 ancestors have a recall of any class; 1 has a Class I recall.
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 CASSATTTM SIJ Fixation 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 as stated in the FDA summary.
https://510kreport.com/device/K211785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211785: CASSATT™ SIJ 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/K211785
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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