510(k) · Cleared

Cleared

Tranquil Interbody System

K170297510(k) TraditionalCleared Jun 27, 2017147-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nexus Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jun 27, 2017 as substantially equivalent to K160547 (K2m, 2016) and 8 other predicates after a 147-day review. Its family tree reaches back 16 generations to 1984. 1 of the 120 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.

Decided: Jun 27, 2017
Review: 147 days
Class: Class II
Product code: MAX
Recalls: None
Predicates: 9

Its longest line of descent runs back 16 generations to K841189 (1984). 104 ancestors in all. 15 later devices descend from it, 6 citing it directly. 1 of the 120 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
12 generations between
3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
2 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
1 generation backK160547 Cascadia Interbody SystemK2m · 2016
This deviceK170297 Tranquil Interbody SystemNexus Spine, LLC · 2017
Descendant · cites it directly · 8 of its ownK181702 Tranquil-L Interbody SystemNexus Spine, LLC · 2018
Descendant · 2 generations on · 7 of its ownK212498 Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022
Descendant · cites it directly · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
Descendant · 2 generations on · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
Descendant · cites it directly · 6 of its ownK181483 Tranquil Interbody SystemNexus 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 backK051454 Aleutian Spacer SystemK2m, LLC · 2005
8 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
7 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
6 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
5 generations backK103169 AleuttianK2m, Inc. · 2011
4 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
3 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
2 generations backK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
1 generation backK160547 Cascadia Interbody SystemK2m · 2016
This deviceK170297 Tranquil Interbody SystemNexus Spine, LLC · 2017

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2018high 4 (2023) · low 0 (2019)2026

Class I recalls in this family

K073202 Ardis Spacer4 generations back · 2008

Most influential descendants

Showing 5 of 15 · See all

K181702Tranquil-L Interbody SystemNexus Spine, LLC · 2018 · cites it directly8descendants
K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC · 2022 · 2 generations on7descendants
K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · cites it directly7descendants
K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on6descendants
K181483Tranquil Interbody SystemNexus Spine, LLC · 2018 · cites it directly6descendants

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	K051454	Aleutian Spacer System	K2m, LLC	2005	—
−8	K063399	Aleutian Spacer System	K2m, Inc.	2007	—
−7	K082698	Aleutian Ibf System	K2m, Inc.	2009	—
−6	K101302	Aleutian Ibf System	K2m, Inc.	2010	—
−5	K103169	Aleuttian	K2m, Inc.	2011	—
−4	K130699	Aleutian Spinal System	K2m, Inc.	2013	—
−3	K133614	Aleutian Ibf System	K2m, Inc.	2014	—
−2	K150481	Cascadia Interbody System	K2m, Inc.	2015	3
−1	K160547	Cascadia Interbody System	K2m	2016	—
0 (this device)	K170297	Tranquil Interbody System	Nexus Spine, LLC	2017	—
+1	K181702	Tranquil-L Interbody System	Nexus Spine, LLC	2018	—
+2	K212498	Stable-L Standalone Lumbar Interbody System	Nexus Spine, LLC	2022	—
+1	K181621	Stable-C Interbody System	Nexus Spine, LLC	2018	—
+2	K231763	Stable-C Interbody System	Nexus Spine, LLC	2023	—
+1	K181483	Tranquil Interbody System	Nexus 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	9	0
2002	7	0
2003	9	0
2004	9	0
2005	4	0
2007	9	0
2008	14	1
2009	10	0
2010	2	0
2011	5	0
2012	3	0
2013	1	0
2014	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	3	0
2020	1	0
2022	2	0
2023	4	0
2024	3	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K170297, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (9)

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	Applicant	Decided	Recalls
*	K160547	Cascadia Interbody System Summary page 4 …r Device 510(k)/PMA Number Primary Predicate K2M Cascadia Interbody System K160547 Other Predicates Adaptive Specialty Fusion Advantage Cervical Cage K083425…	K2m	2016	—
*	K083425	Fusion Advantage Cervical Cage, Fusion Advantage Lumbar Cage Summary page 4 …2M Cascadia Interbody System K160547 Other Predicates Adaptive Specialty Fusion Advantage Cervical Cage K083425 Fusion Advantage Lumbar Cage K2M Aleutian…	Adaptive Specialty, LLC	2009	—
*	K130699	Aleutian Spinal System Summary page 4 …age Cervical Cage K083425 Fusion Advantage Lumbar Cage K2M Aleutian K130699 Spinal Elements Lucent K071724/ K081968 Spinal Elements Crystal…	K2m, Inc.	2013	—
*	K071724	Lucent Summary page 4 …age Lumbar Cage K2M Aleutian K130699 Spinal Elements Lucent K071724/ K081968 Spinal Elements Crystal Cervical Cage K073351 LDR Spine Cervica…	Spinal Elements, Inc.	2007	—
*	K081968	Modification to Lucent Summary page 4 …r Cage K2M Aleutian K130699 Spinal Elements Lucent K071724/ K081968 Spinal Elements Crystal Cervical Cage K073351 LDR Spine Cervical Interbo…	Spinal Elements, Inc.	2008	—
*	K073351	Crystal Summary page 4 …130699 Spinal Elements Lucent K071724/ K081968 Spinal Elements Crystal Cervical Cage K073351 LDR Spine Cervical Interbody Fusion System K091088 Meditech Talos PLIF…	Spinal Elements, Inc.	2008	—
*	K091088	LDR Spine Cervical Interbody Fusion System Summary page 4 …071724/ K081968 Spinal Elements Crystal Cervical Cage K073351 LDR Spine Cervical Interbody Fusion System K091088 Meditech Talos PLIF K090707 Captiva Spine PivoTEC Lumbar I…	Ldr Spine USA	2009	—
*	K090707	Talos Intervertebral Body Fusion Device Summary page 4 …K073351 LDR Spine Cervical Interbody Fusion System K091088 Meditech Talos PLIF K090707 Captiva Spine PivoTEC Lumbar Interbody Fusion K092017 Device (LFID)…	Meditech Advisors, LLC	2009	—
*	K092017	Pivotec Lumbar Interbody Fusion Device (Lifd) Summary page 4 …K091088 Meditech Talos PLIF K090707 Captiva Spine PivoTEC Lumbar Interbody Fusion K092017 Device (LFID) Device Description: The Tranquil Interbody System is made of Ti-6Al-4V E…	Captiva Spine, Inc.	2009	—

Also cleared against K160547: 4 other devices →

What descends from it? (15)

See all 15

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K181702	Tranquil-L Interbody System	Nexus Spine, LLC	2018	8
K181621	Stable-C Interbody System	Nexus Spine, LLC	2018	7
K181483	Tranquil Interbody System	Nexus Spine, LLC	2018	6
K240416	Tranquil-C Interbody System	Nexus Spine, LLC	2024	3
K222806	Kodiak C Spinal Implant System	Met One Technologies, LLC	2022	1
K233375	Tranquil-L Interbody System	Nexus Spine, LLC	2024	0

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 33 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
15 of the 104 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K181702 (Nexus Spine, LLC, 2018) has gone furthest, with 8 descendants of its own.
4 other devices also cite its predicate K160547.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007high 811 (2025) · low 12 (2007)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™ 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™ Cervical Interbody System is intended for spinal fusion procedures at one level in the cervical spine (C3 to C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc…

Read the full statement (214 words)

The Tranquil™ 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™ Cervical Interbody System is intended for spinal fusion procedures at one level in the cervical spine (C3 to C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The cervical device is to be implanted via an open, anterior approach and packed with autogenous bone. The cervical device is to be used in patients who have had six weeks of non-operative treatment. This device system is intended for use with supplemental internal fixation systems.

The Tranquil™ Lumbar 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 1 spondylolisthesis or retrolisthesis at the involved levels. The patients may have had a previous non-fusion spinal surgery at the involved level(s). The device is intended for use with supplemental internal 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/K170297 · printed Nov 4, 2026

Cite this page

510(k) Report. “K170297: Tranquil Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170297

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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