# K232256: Alcantara Thoracolumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies, LLC
- Decided: Apr 16, 2024 after 263 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: 27 generations back to K841189 (1984). 722 ancestors in all.
No later device cites it as a predicate yet.
1 of 723 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171538: Cure™ Lumbar Plate System, Meditech Spine, LLC (2017) Summary page 5.
- K183214: Raven Lumbar Plate System, Choicespine, LP (2019) Summary page 5.
- K162211: AccuFit Lateral Plate System, Precision Spine, Inc. (2016) Summary page 5.
- K220324: AccuFit Lateral 2-Hole Plate, Precision Spine, Inc. (2022) Summary page 5.
- K142699: LITe Plate System, Stryker Corporation (2014) Summary page 5.
- K150449: LITe Plate System, Stryker Corp. (2015) Summary page 5.
- K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System, Corelink, LLC (2023). Cleared while this submission was under review Summary page 5.
- K191584: FORTICO Anterior Cervical Fixation System, Camber Spine Technologies, LLC (2019) Summary page 5.
- K210595: SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers, Camber Spine Technologies, LLC (2021) Summary page 5.

## Indications for use
The Camber Spine Alcantara Thoracolumbar Plate System 2, 3 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 including dislocation and subluxation) Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion. The Camber Spine Alcantara Thoracolumbar 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/K232256
Methodology: https://510kreport.com/methodology