510(k) · Cleared
ClearedTranquil 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 Aug 27, 2018 as substantially equivalent to K170297 (Nexus Spine, LLC, 2017) and 2 other predicates after an 83-day review. Its family tree reaches back 17 generations to 1984. 1 of the 165 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Aug 27, 2018
- Review
- 83 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K841189 (1984). 158 ancestors in all. 6 later devices descend from it, 3 citing it directly. 1 of the 165 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 deviceK181483 Tranquil Interbody SystemNexus Spine, LLC · 2018
- Descendant · cites it directly · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK261279 DeltaNEC Interbody SystemNexus Spine · 2026
- Descendant · 3 generations on · 0 of its ownK243934 Stable-L Lumbar Interbody SystemNexus Spine, LLC · 2025
- Descendant · cites it directly · 0 of its ownK233375 Tranquil-L Interbody SystemNexus Spine, LLC · 2024
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 deviceK181483 Tranquil Interbody SystemNexus Spine, LLC · 2018
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- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · cites it directly3descendants
- K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 2 generations on2descendants
- K261279DeltaNEC Interbody SystemNexus Spine · 2026 · 3 generations on0descendants
- K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC · 2025 · 3 generations on0descendants
- K233375Tranquil-L Interbody SystemNexus Spine, LLC · 2024 · cites it directly0descendants
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) | K181483 | Tranquil Interbody System | Nexus Spine, LLC | 2018 | — |
| +1 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +2 | K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +3 | K261279 | DeltaNEC Interbody System | Nexus Spine | 2026 | — |
| +3 | K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025 | — |
| +1 | K233375 | Tranquil-L Interbody System | Nexus Spine, LLC | 2024 | — |
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 | 11 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 2 | 0 |
| 2007 | 11 | 0 |
| 2008 | 24 | 1 |
| 2009 | 15 | 0 |
| 2010 | 3 | 0 |
| 2011 | 11 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2017 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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? (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 |
|---|---|---|---|
| * | K170297 | Tranquil Interbody SystemSummary page 4…Device 510(k) Number Primary Predicate Nexus Spine LLC Tranquil™ Interbody System K170297 Additional Predicates HD LifeSciences LLC HD Lumbar Interbody System K170676 EIT Emerg… | 2017 |
| * | K170676 | HD Lumbar Interbody SystemSummary page 4…ine LLC Tranquil™ Interbody System K170297 Additional Predicates HD LifeSciences LLC HD Lumbar Interbody System K170676 EIT Emerging Implant EIT Cellular Titanium Cervical Cages, K172888 Technologies GmbH EIT Cellular… | 2017 |
| * | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Summary page 4…al Predicates HD LifeSciences LLC HD Lumbar Interbody System K170676 EIT Emerging Implant EIT Cellular Titanium Cervical Cages, K172888 Technologies GmbH EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF… | 2017 |
| † | K172676 | NuVasive® Modulus-C Interbody System | 2017 |
| † | K173324 | ALTA Anterior Cervical Interbody Spacer | 2018 |
| † | K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | 2017 |
| † | K163491 | NuVasive CoRoent Small Interbody System | 2017 |
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 34 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 22 of the 158 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K240416 (Nexus Spine, LLC, 2024) has gone furthest, with 3 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?
Tranquil-C™ Interbody System The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-C™ Interbody System is also to be used with supplemental fixation…
Read the full statement (205 words)
Tranquil-C™ Interbody System
The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-C™ Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Tranquil-L™ Interbody System
The Tranquil-L™ Interbody System is intended 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 non-operative 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 used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181483: Tranquil Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181483
Report an extraction error
Are you the manufacturer?
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