510(k) · Cleared
ClearedMiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MiRus, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 18, 2020 as substantially equivalent to K182920 (MiRus, LLC, 2019) and 2 other predicates after a 307-day review. Its family tree reaches back 20 generations to 1984. 1 of the 295 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- May 18, 2020
- Review
- 307 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K841189 (1984). 288 ancestors in all. 6 later devices descend from it, 3 citing it directly. 1 of the 295 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 2 generations backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- 1 generation backK182920 MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK…MiRus, LLC · 2019
- This deviceK191906 MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the…MiRus, LLC · 2020
- Descendant · cites it directly · 3 of its ownK212811 Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK230731 Zavation ALIF SystemZavation Medical Products, LLC · 2023
- Descendant · 3 generations on · 1 of its ownK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK250769 Dakota LP SystemPrecision Spine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK232154 MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated…MiRus, LLC · 2023
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- 2 generations backK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- 1 generation backK182920 MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK…MiRus, LLC · 2019
- This deviceK191906 MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the…MiRus, LLC · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 5 of 6 · See all- K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC · 2022 · cites it directly3descendants
- K230731Zavation ALIF SystemZavation Medical Products, LLC · 2023 · 2 generations on2descendants
- K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC · 2024 · 3 generations on1descendant
- K250769Dakota LP SystemPrecision Spine, Inc. · 2025 · 4 generations on0descendants
- K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| −2 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| −1 | K182920 | MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior… | MiRus, LLC | 2019 | — |
| 0 (this device) | K191906 | MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D… | MiRus, LLC | 2020 | — |
| +1 | K212811 | Ti3Z Lumbar Interbody System | Zavation Medical Products, LLC | 2022 | — |
| +2 | K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023 | — |
| +3 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer… | Zavation Medical Products, LLC | 2024 | — |
| +4 | K250769 | Dakota LP System | Precision Spine, Inc. | 2025 | — |
| +1 | K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | MiRus, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 16 | 0 |
| 2004 | 23 | 0 |
| 2005 | 20 | 0 |
| 2006 | 7 | 0 |
| 2007 | 12 | 0 |
| 2008 | 43 | 1 |
| 2009 | 30 | 0 |
| 2010 | 18 | 0 |
| 2011 | 25 | 0 |
| 2012 | 9 | 0 |
| 2013 | 14 | 0 |
| 2014 | 15 | 0 |
| 2015 | 7 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K182920 | MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…Summary page 4…aditional 510(k) V. PREDICATE DEVICE Primary Predicate MiRus Lumbar Interbody Fusion System (K182920) Additional Predicates EIT Cellular Titanium® Lumbar Cage (K17288… | 2019 |
| * | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Summary page 4…ystem (K182920) Additional Predicates EIT Cellular Titanium® Lumbar Cage (K172888, K181644) VI. DEVICE DESCRIPTION The MiRus™ 3D Printed Lumbar Interbody Fusion System consist of implants manufactured from tita… | 2017 |
| * | K181644 | EIT Cellular Titanium® Lumbar Cage LLIFSummary page 4…(K182920) Additional Predicates EIT Cellular Titanium® Lumbar Cage (K172888, K181644) VI. DEVICE DESCRIPTION The MiRus™ 3D Printed Lumbar Interbody Fusion System consist of implants manufactured from titanium allo… | 2018 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 33 of the 288 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212811 (Zavation Medical Products, LLC, 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K182920.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The MiRus™ 3D Printed Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the…
Read the full statement (114 words)
The MiRus™ 3D Printed Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191906 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191906: MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191906
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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