# K080411: Plateau Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: May 15, 2008 after 90 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
No predicates in its family tree.
764 later devices descend from it; 15 cite it directly.
1 of 765 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100865: Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX (2010), 637 descendants of its own
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System (2015), 636 descendants of its own
- K091301: Life Spine Stand-Alone Spacer System (2009), 473 descendants of its own
- K143616: AccuLIF TL and PL Cage (2015), 469 descendants of its own
- K100802: Aesculap Implant Systems Sibd Spinal System (2010), 461 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 1 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/K080411
Methodology: https://510kreport.com/methodology