# K172131: 2 Hole Lateral Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Aug 28, 2017 after 45 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: 9 generations back to K990745 (1999). 46 ancestors in all.
10 later devices descend from it; 2 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)
- K140260: Skyhawk Lateral Plate System, Orthofix, Inc. (2014) Summary page 4.
- K133194: Diamond Rattlesnake System, Eminent Spine (2014) Summary page 4.
- K120092: Plymouth Thoracolumbar Plate System, Globus Medical, Inc. (2012) Summary page 4.
- K091071: Nuvasive Lateral Plate System, Nuvasive, Inc. (2009) Summary page 4.
- K132589: Anterior Lumbar Plate System (Presidio), Life Spine, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- K253748: Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System (2026), 0 descendants of its own

## Indications for use
The 2 Hole Lateral Plating 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)

Source page: https://510kreport.com/device/K172131
Methodology: https://510kreport.com/methodology