510(k) · Cleared
ClearedRubicon Lumbar Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rubicon Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 17, 2018 as substantially equivalent to K151819 (Integrity Spine Lumbar Interbody Fusion System, 2015) and 7 other predicates after a 90-day review. Its family tree reaches back 16 generations to 1984. 1 of the 101 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 17, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 16 generations to K841189 (1984). 100 ancestors in all. No later device cites it as a predicate yet. 1 of the 101 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK111166 A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC · 2011
- 2 generations backK121693 A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc. · 2012
- 1 generation backK141443 Infront Lumbar Interbody Fusion SystemInfront Medical, LLC · 2014
- This deviceK181030 Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC · 2018
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 3 generations backK111166 A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC · 2011
- 2 generations backK121693 A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc. · 2012
- 1 generation backK141443 Infront Lumbar Interbody Fusion SystemInfront Medical, LLC · 2014
- This deviceK181030 Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC · 2018
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −3 | K111166 | A-Wedge Anterior Interbody System (a-Wedge a.I.S.) | Spineworks, LLC | 2011 | — |
| −2 | K121693 | A-Wedge Anterior Interbody System (a-Wedge Ais) | Sapphire Medical Group, Inc. | 2012 | — |
| −1 | K141443 | Infront Lumbar Interbody Fusion System | Infront Medical, LLC | 2014 | — |
| 0 (this device) | K181030 | Rubicon Lumbar Interbody Fusion System | Rubicon Spine, LLC | 2018 | — |
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 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 14 | 1 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2015 | 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? (8)
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 |
|---|---|---|---|
| * | K151819 | Integrity Spine Lumbar Interbody Fusion SystemSummary page 5…ces that are currently on the market in the US, including the following: Primary Predicate x Integrity Spine Lumbar Interbody Fusion System (K151819, November 10, 2015) Additional Predicates x Vertebron Interbody Fusion System (K073502, March 24, 2008)… | 2015 |
| * | K073502 | Vertebron VBR SystemSummary page 5…e x Integrity Spine Lumbar Interbody Fusion System (K151819, November 10, 2015) Additional Predicates x Vertebron Interbody Fusion System (K073502, March 24, 2008) x Synthes Opal and Oracle Spacer (K072791, December 26, 2007) x Stryker AVS PL Spacer (K0908… | 2008 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 5…, November 10, 2015) Additional Predicates x Vertebron Interbody Fusion System (K073502, March 24, 2008) x Synthes Opal and Oracle Spacer (K072791, December 26, 2007) x Stryker AVS PL Spacer (K090816, April 24, 2009) x Stryker AVS TL Spacer (K083661, Febru… | 2007 |
| * | K090816 | Stryker Spine Avs PL Peek SpacersSummary page 5…x Vertebron Interbody Fusion System (K073502, March 24, 2008) x Synthes Opal and Oracle Spacer (K072791, December 26, 2007) x Stryker AVS PL Spacer (K090816, April 24, 2009) x Stryker AVS TL Spacer (K083661, February 27, 2009) x Synthes TPAL Spacer (K100089, May 13,… | 2009 |
| * | K083661 | Avs TL Peek SpacersSummary page 5…8) x Synthes Opal and Oracle Spacer (K072791, December 26, 2007) x Stryker AVS PL Spacer (K090816, April 24, 2009) x Stryker AVS TL Spacer (K083661, February 27, 2009) x Synthes TPAL Spacer (K100089, May 13, 2010) x Stryker AVS ARIA Spacer (K101051 August 1… | 2009 |
| * | K100089 | Synthes T-Pal SpacerSummary page 5…ber 26, 2007) x Stryker AVS PL Spacer (K090816, April 24, 2009) x Stryker AVS TL Spacer (K083661, February 27, 2009) x Synthes TPAL Spacer (K100089, May 13, 2010) x Stryker AVS ARIA Spacer (K101051 August 12, 2010) x InFront Lumbar Interbody Fusion System (… | 2010 |
| * | K101051 | Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXSummary page 5…ril 24, 2009) x Stryker AVS TL Spacer (K083661, February 27, 2009) x Synthes TPAL Spacer (K100089, May 13, 2010) x Stryker AVS ARIA Spacer (K101051 August 12, 2010) x InFront Lumbar Interbody Fusion System (K141443, August 28, 2014)… | 2010 |
| * | K141443 | Infront Lumbar Interbody Fusion SystemSummary page 5…x Synthes TPAL Spacer (K100089, May 13, 2010) x Stryker AVS ARIA Spacer (K101051 August 12, 2010) x InFront Lumbar Interbody Fusion System (K141443, August 28, 2014) K181030 -… | 2014 |
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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 15 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 100 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K151819.
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. 2018, 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 Rubicon Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181030: Rubicon Lumbar Interbody 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/K181030
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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