510(k) · Cleared
ClearedTranquil-L Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexus Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 21, 2018 as substantially equivalent to K170297 (Nexus Spine, LLC, 2017) and 3 other predicates after an 86-day review. Its family tree reaches back 17 generations to 1984. 1 of the 120 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Sep 21, 2018
- Review
- 86 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K841189 (1984). 111 ancestors in all. 8 later devices descend from it, 2 citing it directly. 1 of the 120 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- 2 generations backK160547 Cascadia Interbody SystemK2m · 2016
- 1 generation backK170297 Tranquil Interbody SystemNexus Spine, LLC · 2017
- This deviceK181702 Tranquil-L Interbody SystemNexus Spine, LLC · 2018
- Descendant · cites it directly · 7 of its ownK212498 Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022
- Descendant · 2 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 3 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 3 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 2 generations on · 1 of its ownK231486 Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2023
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 9 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 8 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 7 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 6 generations backK103169 AleuttianK2m, Inc. · 2011
- 5 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 4 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 3 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- 2 generations backK160547 Cascadia Interbody SystemK2m · 2016
- 1 generation backK170297 Tranquil Interbody SystemNexus Spine, LLC · 2017
- This deviceK181702 Tranquil-L Interbody SystemNexus Spine, LLC · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 8 · See all- K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022 · cites it directly7descendants
- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on5descendants
- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 3 generations on3descendants
- K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 3 generations on2descendants
- K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −9 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −8 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −7 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −6 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −5 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −4 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −3 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| −2 | K160547 | Cascadia Interbody System | K2m | 2016 | — |
| −1 | K170297 | Tranquil Interbody System | Nexus Spine, LLC | 2017 | — |
| 0 (this device) | K181702 | Tranquil-L Interbody System | Nexus Spine, LLC | 2018 | — |
| +1 | K212498 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2022 | — |
| +2 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +3 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +3 | K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +2 | K231486 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, 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 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2007 | 10 | 0 |
| 2008 | 16 | 1 |
| 2009 | 11 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K170297 | Tranquil Interbody SystemSummary page 4…Device 510(k) Number Primary Predicate Nexus Spine LLC Tranquil-L Interbody System K170297 Additional Predicates HD LifeSciences LLC HD Lumbar Interbody System K170676 DePuy S… | 2017 |
| * | K170676 | HD Lumbar Interbody SystemSummary page 4…LLC Tranquil-L Interbody System K170297 Additional Predicates HD LifeSciences LLC HD Lumbar Interbody System K170676 DePuy Synthes Spine Synthes SynCage Evolution Spacer K122639 Captiva Spine LLC Pivotec Lu… | 2017 |
| * | K122639 | Synthes Syncage Evolution SpacerSummary page 4…redicates HD LifeSciences LLC HD Lumbar Interbody System K170676 DePuy Synthes Spine Synthes SynCage Evolution Spacer K122639 Captiva Spine LLC Pivotec Lumbar Interbody System K092017 Device Description: The Tranquil… | 2013 |
| * | K092017 | Pivotec Lumbar Interbody Fusion Device (Lifd)Summary page 4…K170676 DePuy Synthes Spine Synthes SynCage Evolution Spacer K122639 Captiva Spine LLC Pivotec Lumbar Interbody System K092017 Device Description: The Tranquil-L Interbody System is made of Ti-6Al-4V ELI. The implant is… | 2009 |
What descends from it? (8)
2 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 · 5 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 10 companies; a new generation was cleared every 1.3 years on median.
- 17 of the 111 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212498 (Nexus Spine, LLC, 2022) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K170297.
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 Tranquil-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The Tranquil-L Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed…
Read the full statement (119 words)
The Tranquil-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.
The Tranquil-L Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The patients may have had a previous non-fusion spinal surgery at the involved level(s). The Tranquil-L device is intended to be used with FDA cleared supplemental fixation systems.
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/K181702 · printed Nov 3, 2026
Cite this page
510(k) Report. “K181702: Tranquil-L Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K181702
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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