# K111569: Plateau Spacer System

- Pathway: 510(k) (Special)
- Applicant: Life Spine
- Decided: Jul 6, 2011 after 30 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: 10 generations back to K841189 (1984). 31 ancestors in all.
181 later devices descend from it; 7 cite it directly.
0 of 213 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.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 1.
- K081177: Blackstone Medical, Inc., Pillar Spacer System, Blackstone Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K120991: TRANS1 Interbody Fusion System (2012), 172 descendants of its own
- K153107: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System (2016), 171 descendants of its own
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (2016), 161 descendants of its own
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (2017), 116 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 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 (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD 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 that is cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K111569
Methodology: https://510kreport.com/methodology