# K142699: LITe Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Dec 31, 2014 after 100 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: 7 generations back to K990745 (1999). 42 ancestors in all.
46 later devices descend from it; 8 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001844: Modification to Centaur Spinal System, Howmedica Osteonics Corp. (2000) Summary page 4.
- K994347: Centaur Spinal System, Howmedica Osteonics Corp. (2000) Summary page 4.
- K080429: Modificaton to: Pyramid +4 Anterior Lumbar Plate System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.
- K091071: Nuvasive Lateral Plate System, Nuvasive, Inc. (2009) Summary page 4.
- K091044: Spinal Usa Anterior Lumbar Plate System, Spinal USA (2009) Summary page 4.
- K062836: Citadel Anterior Lumbar Plate System, Globus Medical, Inc. (2006) Summary page 4.
- K080773: Thor Anterior Plating System, Stryker Spine (2008) Summary page 4.
- K092659: Spinal Usa RCS Anterior Lumbar Butress Plate System, Model 22-1001-25, Spinal USA (2009) Summary page 4.

## Most influential descendants
- K150449: LITe Plate System (2015), 24 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K192481: AccelFix Lumbar Plate System (2020), 13 descendants of its own
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (2021), 10 descendants of its own
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS) (2021), 9 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/K142699
Methodology: https://510kreport.com/methodology
