# K130630: Plateau Spacer System Titanium

- Pathway: 510(k) (Special)
- Applicant: Life Spine, Inc.
- Decided: Jun 13, 2013 after 97 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: 3 generations back to K071922 (2007). 4 ancestors in all.
17 later devices descend from it; 6 cite it directly.
0 of 22 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.
- K120918: Nuvasive Coroent Titanium System, Nuvasive, Inc. (2012) Summary page 1.

## Most influential descendants
- K170512: Altus Spine Titanium Interbody Fusion System (2017), 6 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
- K171329: Altus Spine Titanium Interbody Fusion System (2017), 2 descendants of its own
- K221806: TruLift Lateral Expandable Spacer System & Lateral Plate System (2022), 1 descendant of its own
- K193521: Steerable Plateau Ti (2020), 1 descendant 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 (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K130630
Methodology: https://510kreport.com/methodology