# K231232: Curiteva Laminoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Curiteva, Inc.
- Decided: Jun 28, 2023 after 61 days
- Product code: NQW (Orthosis, Spine, Plate, Laminoplasty, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K761228 (1976). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032534: Synthes Afs, Synthes Spine (2004) Summary page 4.
- K173215: Choice Spine Laminoplasty™ Fixation System, Choicespine, LP (2018) Summary page 4.
- K121732: Canopy Laminoplasty Fixation System, Globus Medical, Inc. (2012) Summary page 4.
- K091623: Laminoplasty Fixation System, Nuvasive, Inc. (2009) Summary page 4.

## Most influential descendants
- K243137: Curiteva Porous PEEK Laminoplasty System (2024), 1 descendant of its own
- K252205: Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System (2026), 0 descendants of its own

## Indications for use
The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

Source page: https://510kreport.com/device/K231232
Methodology: https://510kreport.com/methodology