# K252930: AQUA Laminoplasty Systems

- Pathway: 510(k) (Traditional)
- Applicant: ZheJiang Decans Medical Devices Co., Ltd.
- Decided: May 27, 2026 after 254 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: 4 generations back to K761228 (1976). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212428: Centerpiece Plate Fixation System, Medtronic Sofamor Danek (2021) Summary page 6.
- K091994: Mountaineer Laminoplasty System, Depuy Spine, Inc. (2010) Summary page 6.
- K191169: NuVasive® Camber Laminoplasty System, Nu Vasive, Incorporated (2019) Summary page 6.
- K032534: Synthes Afs, Synthes Spine (2004) Summary page 6.

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

Source page: https://510kreport.com/device/K252930
Methodology: https://510kreport.com/methodology