# K233360: Curiteva Thoracolumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Curiteva, Inc.
- Decided: Feb 29, 2024 after 153 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). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171538: Cure™ Lumbar Plate System, Meditech Spine, LLC (2017) Summary page 4.
- K180090: Cure™ Lumbar Plate System, Meditech Spine, LLC (2018) Summary page 4.
- K142699: LITe Plate System, Stryker Corporation (2014) Summary page 4.
- K173885: Genesys Spine Binary Lumbar Plate System, Genesys Spine (2018) Summary page 4.
- K181063: Kestrel™ Buttress Plate System, Innovasis, Inc. (2018) Summary page 4.

## Indications for use
The Curiteva Thoracolumbar Plate System Two Hole and Four Hole Plates are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability, or via the anterior surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients 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), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved. The Curiteva 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/K233360
Methodology: https://510kreport.com/methodology