# K132589: Anterior Lumbar Plate System (Presidio)

- Pathway: 510(k) (Special)
- Applicant: Life Spine, Inc.
- Decided: Oct 8, 2013 after 50 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: 3 generations back to K922543 (1993). 6 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093200: Life Spine Lumbar Plate System, Life Spine (2010) Summary page 1.
- K043548: Blackstone Unity Anterior Lumbar Plate Fixation System, Blackstone Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K172131: 2 Hole Lateral Plating System (2017), 10 descendants of its own
- K180166: Life Spine Lumbar Fixation System (SENTRY) (2018), 9 descendants of its own
- 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

## Indications for use
The Life Spine Anterior Lumbar Fixation System (Presidio) 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 (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LI-SI) 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/K132589
Methodology: https://510kreport.com/methodology