# K170297: Tranquil Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: Jun 27, 2017 after 147 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K841189 (1984). 104 ancestors in all.
15 later devices descend from it; 6 cite it directly.
1 of 120 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160547: Cascadia Interbody System, K2m (2016) Summary page 4.
- K083425: Fusion Advantage Cervical Cage, Fusion Advantage Lumbar Cage, Adaptive Specialty, LLC (2009) Summary page 4.
- K130699: Aleutian Spinal System, K2m, Inc. (2013) Summary page 4.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 4.
- K081968: Modification to Lucent, Spinal Elements, Inc. (2008) Summary page 4.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 4.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 4.
- K090707: Talos Intervertebral Body Fusion Device, Meditech Advisors, LLC (2009) Summary page 4.
- K092017: Pivotec Lumbar Interbody Fusion Device (Lifd), Captiva Spine, Inc. (2009) Summary page 4.

## Most influential descendants
- K181702: Tranquil-L Interbody System (2018), 8 descendants of its own
- K212498: Stable-L Standalone Lumbar Interbody System (2022), 7 descendants of its own
- K181621: Stable-C Interbody System (2018), 7 descendants of its own
- K231763: Stable-C Interbody System (2023), 6 descendants of its own
- K181483: Tranquil Interbody System (2018), 6 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K170297
Methodology: https://510kreport.com/methodology