# K233375: Tranquil-L Interbody System

- Pathway: 510(k) (Special)
- Applicant: Nexus Spine, LLC
- Decided: Mar 20, 2024 after 170 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: 27 generations back to K841189 (1984). 560 ancestors in all.
No later device cites it as a predicate yet.
1 of 561 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181702: Tranquil-L Interbody System, Nexus Spine, LLC (2018) Summary page 4.
- K170297: Tranquil Interbody System, Nexus Spine, LLC (2017) Summary page 5.
- K181483: Tranquil Interbody System, Nexus Spine, LLC (2018) Summary page 5.
- K122989: Biomet Lateral Spacer System, Biomet Spine (Aka Ebi, LLC) (2012) Summary page 5.
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System, Nexus Spine, LLC (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K233375
Methodology: https://510kreport.com/methodology