# K172105: The Plateau-LO Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Feb 2, 2018 after 205 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: 18 generations back to K841189 (1984). 341 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 343 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 4.
- K151116: CapLOX II/TowerLOX Pedicle Screw System, Captiva Spine (2015) Summary page 4.
- K153400: ProLift Expandable System, Life Spine, Inc. (2016) Summary page 4.
- K151665: SUSTAIN Additional Implants, Globus Medical, Inc. (2016) Summary page 4.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 4.

## Most influential descendants
- K182470: Plateau Spacer System (2018), 0 descendants of its own

## Indications for use
The Plateau-LO 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 (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K172105
Methodology: https://510kreport.com/methodology