# K243668: ProLift Pivot Expandable Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Jan 23, 2025 after 57 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: 22 generations back to K841189 (1984). 218 ancestors in all.
No later device cites it as a predicate yet.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190488: ProLift Expandable System, Life Spine, Inc. (2019) Summary page 5.
- K202298: Lucent XP, Lucent XP Curved, Spinal Elements, Inc. (2020) Summary page 5.
- K140411: Altera Spacer, Globus Medical, Inc. (2014) Summary page 5.
- K212520: ProLift Micro Expandable Spacer System, Life Spine, Inc. (2021) Summary page 5.
- K223430: ProLift Micro Expandable Spacer System, Life Spine, Inc. (2023) Summary page 5.
- K193521: Steerable Plateau Ti, Life Spine, Inc. (2020) Summary page 5.

## Indications for use
The Prolift Pivot Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels (L2-S1 ). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DOD 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/K243668
Methodology: https://510kreport.com/methodology