510(k) · Cleared
ClearedRIGEL™ 3DR Anterior Cervical Corpectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MiRus, LLC · PLR Spinal Vertebral Body Replacement Device - Cervical
Cleared on Oct 13, 2023 as substantially equivalent to K193412 (Nexxt Spine, LLC, 2020) and 1 other predicate after a 58-day review. Its family tree reaches back 24 generations to 1984. 1 of the 258 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 13, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- PLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 24 generations to K841189 (1984). 257 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 258 devices in this family, counting this one, has a Class I recall.
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations between
- 3 generations backK171704 CAPRI Corpectomy Cage SystemK2m · 2017
- 2 generations backK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
- 1 generation backK193412 NEXXT MATRIXX SystemNexxt Spine, LLC · 2020
- This deviceK232481 RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC · 2023
Show all 24 generations
- Root · 24 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 22 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 21 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 18 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 17 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 14 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 13 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 12 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 11 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 10 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 9 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 8 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 7 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 6 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 5 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 4 generations backK170055 CAPRI Corpectomy Cage SystemK2m · 2017
- 3 generations backK171704 CAPRI Corpectomy Cage SystemK2m · 2017
- 2 generations backK180665 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC · 2018
- 1 generation backK193412 NEXXT MATRIXX SystemNexxt Spine, LLC · 2020
- This deviceK232481 RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC · 2023
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −23 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −22 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −21 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −18 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −17 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −14 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −13 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −12 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −11 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −10 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −9 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −8 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −7 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −6 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −5 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −4 | K170055 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| −3 | K171704 | CAPRI Corpectomy Cage System | K2m | 2017 | — |
| −2 | K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | 2018 | — |
| −1 | K193412 | NEXXT MATRIXX System | Nexxt Spine, LLC | 2020 | — |
| 0 (this device) | K232481 | RIGEL™ 3DR Anterior Cervical Corpectomy System | MiRus, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 16 | 0 |
| 2004 | 27 | 0 |
| 2005 | 18 | 0 |
| 2006 | 13 | 0 |
| 2007 | 12 | 0 |
| 2008 | 37 | 1 |
| 2009 | 21 | 0 |
| 2010 | 9 | 0 |
| 2011 | 17 | 0 |
| 2012 | 11 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 PLR device
- #1 K211320 CAPRI Corpectomy Cage Systemscore 12.5 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K193412 | NEXXT MATRIXX SystemSummary page 4…Type Traditional 510(k) V. PREDICATE DEVICE Primary Predicate NEXXT MATRIXX® System – Nexxt Spine LLC (K193412) Additional Predicate C-VBR – Cardinal Spine, LLC (K152568)… | 2020 |
| * | K152568 | C-VBRSummary page 4…NEXXT MATRIXX® System – Nexxt Spine LLC (K193412) Additional Predicate C-VBR – Cardinal Spine, LLC (K152568) Reference Devices RIGEL™ 3DR Anterior Cervical Interbody F… | 2016 |
| † | K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion System | 2020 |
| † | K030744 | Blackstone Surgical Titanium Mesh | 2003 |
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 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 16 companies; a new generation was cleared every 11 months on median.
- 29 of the 257 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All PLR devicesPLR Spinal Vertebral Body Replacement Device - Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLR
69in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLR
No recall names PLR since 2007.
Adverse event reports per year · PLR
1in 2025
MAUDE reports naming product code PLR, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 259 | 0 | 1 |
| 2019 | 5 | 69 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2- T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative…
Read the full statement (168 words)
The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2- T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232481: RIGEL™ 3DR Anterior Cervical Corpectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232481
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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