# K191005: ProLift® Expandable System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Jun 13, 2019 after 58 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: 17 generations back to K841189 (1984). 152 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173182: ProLift® Expandable System, Life Spine, Inc. (2017) Summary page 4.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K080411: Plateau Spacer System, Life Spine (2008) Summary page 4.

## Most influential descendants
- K222455: Calibrate LTX Interbody System (2022), 8 descendants of its own
- K223611: Calibrate LTX Interbody System (2023), 7 descendants of its own
- K200338: ProLift Lateral Fixated (2020), 5 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own
- K210061: ProLift Lateral HELO Fixated (2021), 3 descendants of its own

## Indications for use
When used as an interbody fusion device, the ProLift® Expandable 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. 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/K191005
Methodology: https://510kreport.com/methodology