# K111835: Plateau Spacer System

- Pathway: 510(k) (Special)
- Applicant: Life Spine, Inc.
- Decided: Jul 19, 2011 after 20 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: 12 generations back to K841189 (1984). 40 ancestors in all.
120 later devices descend from it; 2 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093093: Small Plateau Spacer System, Life Spine (2010). Our reading of the summary gave K093043, FDA’s number for Zirconia Syringe Needle (Kuo Tai Hospital Managements & Consultant Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Plateau Spacer System”.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 1.

## Most influential descendants
- K121151: Pro-Link Cervical Spacer System (2012), 116 descendants of its own
- K132029: Vault-C Intervertebral Body Fusion Device (2013), 108 descendants of its own
- K190546: NEXXT MATRIXX Stand Alone Cervical System (2019), 93 descendants of its own
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), 72 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own

## Indications for use
The Small PLATEAU 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/K111835
Methodology: https://510kreport.com/methodology