# K213417: Ghost Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Sep 29, 2022 after 344 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: 27 generations back to K841189 (1984). 460 ancestors in all.
No later device cites it as a predicate yet.
1 of 461 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080411: Plateau Spacer System, Life Spine (2008) Summary page 4.
- K111569: Plateau Spacer System, Life Spine (2011) Summary page 4.
- K201500: Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer, Life Spine, Inc. (2020) Summary page 4.
- K190488: ProLift Expandable System, Life Spine, Inc. (2019) Summary page 4.
- K173182: ProLift® Expandable System, Life Spine, Inc. (2017) Summary page 4.
- K172816: TiGer Shark™ System, Choicespine, LP (2018) Summary page 4.

## Indications for use
The Ghost 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone 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/K213417
Methodology: https://510kreport.com/methodology