# K121116: Plateau Spacer System

- Pathway: 510(k) (Special)
- Applicant: Life Spine
- Decided: May 8, 2012 after 26 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: 11 generations back to K841189 (1984). 37 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080411: Plateau Spacer System, Life Spine (2008) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- K112496: Pioneer Crossfuse II Ibf/VBR System, Pioneer Surgical Technology, Inc. (2011)

## Most influential descendants
- K131077: Life Spine Plateau Spacer System (2013), 10 descendants of its own
- K133717: Longbow Spacer System (2014), 9 descendants of its own
- K201721: TruLift Expandable Spacer System (2020), 5 descendants of its own
- K210061: ProLift Lateral HELO Fixated (2021), 3 descendants of its own
- K201500: Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer (2020), 3 descendants of its own

## Indications for use
The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels (L2-S 1). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ODD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K121116
Methodology: https://510kreport.com/methodology