# K210061: ProLift Lateral HELO Fixated

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Apr 30, 2021 after 109 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: 19 generations back to K841189 (1984). 354 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 358 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200338: ProLift Lateral Fixated, Life Spine, Inc. (2020) Summary page 4.
- K201721: TruLift Expandable Spacer System, Life Spine, Inc. (2020) Summary page 4.
- K173182: ProLift® Expandable System, Life Spine, Inc. (2017) Summary page 5.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016) Summary page 4.
- K080411: Plateau Spacer System, Life Spine (2008) Summary page 4.

## Most influential descendants
- K221806: TruLift Lateral Expandable Spacer System & Lateral Plate System (2022), 1 descendant of its own
- K251502: TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System (2025), 0 descendants of its own
- K223335: SIRION Lateral Lumbar Interbody System (2023), 0 descendants of its own

## Indications for use
The ProLift Lateral HELO Fixated is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The ProLift Lateral HELO Fixated is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The ProLift Lateral HELO Fixated must be used with FDA cleared supplemental fixation. The ProLift Lateral HELO Fixated may optionally be used with two bone screws.

Source page: https://510kreport.com/device/K210061
Methodology: https://510kreport.com/methodology