# K180166: Life Spine Lumbar Fixation System (SENTRY)

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Jun 22, 2018 after 151 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K990745 (1999). 47 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172131: 2 Hole Lateral Plating System, Life Spine, Inc. (2017) Summary page 4.
- K132589: Anterior Lumbar Plate System (Presidio), Life Spine, Inc. (2013) Summary page 4.

## Most influential descendants
- K200338: ProLift Lateral Fixated (2020), 5 descendants of its own
- K210061: ProLift Lateral HELO Fixated (2021), 3 descendants of its own
- K221806: TruLift Lateral Expandable Spacer System & Lateral Plate System (2022), 1 descendant of its own
- K253748: Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System (2026), 0 descendants of its own
- K251502: TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System (2025), 0 descendants of its own

## Indications for use
The Life Spine Lumbar Fixation System (SENTRY®) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K180166
Methodology: https://510kreport.com/methodology