# K122822: Spectrum Spine Laminoplasty Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Spine, LLC
- Decided: Feb 7, 2013 after 146 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). 12 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 18 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.
- K050082: Centerpiece Plate Fixation System, Medtronic Sofamor Danek, Inc. (2005) Summary page 1.

## Most influential descendants
- K173215: Choice Spine Laminoplasty™ Fixation System (2018), 4 descendants of its own
- K231232: Curiteva Laminoplasty System (2023), 2 descendants of its own
- 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
- K191927: Hinged Laminoplasty System (2019), 0 descendants of its own

## Indications for use
The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

Source page: https://510kreport.com/device/K122822
Methodology: https://510kreport.com/methodology