# K091623: Laminoplasty Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Oct 9, 2009 after 128 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: 3 generations back to K761228 (1976). 11 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 19 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 1.

## Most influential descendants
- K231232: Curiteva Laminoplasty System (2023), 2 descendants of its own
- K130830: Integra Laminoplasty System (2013), 2 descendants of its own
- K243137: Curiteva Porous PEEK Laminoplasty System (2024), 1 descendant of its own
- K150469: Integra Laminoplasty System (2015), 1 descendant of its own
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K091623
Methodology: https://510kreport.com/methodology