# K193521: Steerable Plateau Ti

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Feb 6, 2020 after 49 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). 157 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 159 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.
- K111569: Plateau Spacer System, Life Spine (2011) Summary page 4.
- K130630: Plateau Spacer System Titanium, Life Spine, Inc. (2013) Summary page 4.
- K190488: ProLift Expandable System, Life Spine, Inc. (2019) Summary page 4.
- K122097: Patriot Spacers, Globus Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- K243668: ProLift Pivot Expandable Spacer System (2025), 0 descendants of its own

## Indications for use
The Steerable Plateau TI 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. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. 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/K193521
Methodology: https://510kreport.com/methodology