# K221806: TruLift Lateral Expandable Spacer System & Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Dec 5, 2022 after 166 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). 566 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 568 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191005: ProLift® Expandable System, Life Spine, Inc. (2019) Summary page 5.
- K201721: TruLift Expandable Spacer System, Life Spine, Inc. (2020) Summary page 5.
- K210061: ProLift Lateral HELO Fixated, Life Spine, Inc. (2021) Summary page 5.
- K201500: Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer, Life Spine, Inc. (2020) Summary page 5.
- K202495: SIRION Lateral Lumbar Interbody Fusion, Astura Medical, LLC (2021) Summary page 5.
- K172131: 2 Hole Lateral Plating System, Life Spine, Inc. (2017) Summary page 5.

## Most influential descendants
- K251502: TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System (2025), 0 descendants of its own

## Indications for use
When used as an interbody fusion device, the TruLift® Lateral Expandable 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. 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. The TruLift® Lateral Expandable Spacer can also be connected to the Lateral Plate System by a set screw. The Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications: -Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) -Spondylolisthesis -Spinal stenosis -Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis) -Tumor -Pseudoarthrosis -Failed previous fusion -Trauma (i.e., fracture or dislocation) The Lateral Plate System, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. The Lateral Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw.

Source page: https://510kreport.com/device/K221806
Methodology: https://510kreport.com/methodology