# K161127: The Small PLATEAU (PLATEAU-C) Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Dec 22, 2016 after 245 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 13 generations back to K003155 (2001). 67 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111835: Plateau Spacer System, Life Spine, Inc. (2011) Summary page 4.
- K100889: Endoskeleton TC, Titan Spine, LLC (2010) Summary page 4.

## Most influential descendants
- K180642: Pro-Link® Ti Stand-Alone Cervical Spacer System (2018), 2 descendants of its own
- K173128: Alamo® C (2018), 2 descendants of its own
- K252737: DeGen Medical Latitude-C AM Cervical Interbody Fusion System (2025), 0 descendants of its own
- K231704: Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System (2023), 0 descendants of its own
- K213115: CHENA-C Spacer System (2021), 0 descendants of its own

## Indications for use
The Small PLATEAU (PLATEAU-C) Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.

Source page: https://510kreport.com/device/K161127
Methodology: https://510kreport.com/methodology