# K093093: Small Plateau Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: Oct 13, 2010 after 377 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: 11 generations back to K841189 (1984). 39 ancestors in all.
393 later devices descend from it; 3 cite it directly.
1 of 433 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 2.
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 2.
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 2.

## Most influential descendants
- K111264: Cornerstone (R) PSR Cervical Fusion System (2011), 331 descendants of its own
- K112444: Anatomic Peek Cervical Fusion System (2011), 324 descendants of its own
- K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst (2013), 281 descendants of its own
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (2015), 228 descendants of its own
- K152277: PIVOX (tm) Oblique Lateral Spinal System (2015), 190 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-Ti). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.

Source page: https://510kreport.com/device/K093093
Methodology: https://510kreport.com/methodology