# K150449: LITe Plate System

- Pathway: 510(k) (Special)
- Applicant: Stryker Corp.
- Decided: Mar 20, 2015 after 28 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: 8 generations back to K990745 (1999). 43 ancestors in all.
24 later devices descend from it; 6 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142699: LITe Plate System, Stryker Corporation (2014) Summary page 5.
- K994347: Centaur Spinal System, Howmedica Osteonics Corp. (2000) Summary page 5.
- K001844: Modification to Centaur Spinal System, Howmedica Osteonics Corp. (2000) Summary page 5.

## Most influential descendants
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS) (2021), 9 descendants of its own
- K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (2023), 3 descendants of its own
- K223362: Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device (2023), 3 descendants of its own
- K220324: AccuFit Lateral 2-Hole Plate (2022), 3 descendants of its own

## Indications for use
The LITe® Plate System Universal, Sacral, 2 Screw and 4 Screw Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: • 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; • Spinal stenosis; • Tumors; • Trauma (i.e. Fractures or Dislocation) • Deformities (i.e. Scoliosis, Kyphosis or Lordosis) • Failed Previous Fusion The LITe® Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Source page: https://510kreport.com/device/K150449
Methodology: https://510kreport.com/methodology