# K181702: Tranquil-L Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Spine, LLC
- Decided: Sep 21, 2018 after 86 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: 17 generations back to K841189 (1984). 111 ancestors in all.
8 later devices descend from it; 2 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)
- K170297: Tranquil Interbody System, Nexus Spine, LLC (2017) Summary page 4.
- K170676: HD Lumbar Interbody System, Hd Lifesciences, LLC (2017) Summary page 4.
- K122639: Synthes Syncage Evolution Spacer, Synthes (USA) Products, LLC (2013) Summary page 4.
- K092017: Pivotec Lumbar Interbody Fusion Device (Lifd), Captiva Spine, Inc. (2009) Summary page 4.

## Most influential descendants
- K212498: Stable-L Standalone Lumbar Interbody System (2022), 7 descendants of its own
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own
- K240416: Tranquil-C Interbody System (2024), 3 descendants of its own
- K241467: Stable-C Interbody System (2024), 2 descendants of its own
- K231486: Stable-L Standalone Lumbar Interbody System (2023), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K181702
Methodology: https://510kreport.com/methodology