Cleared Traditional

K252930 - AQUA Laminoplasty Systems

K252930 is an FDA 510(k) clearance for AQUA Laminoplasty Systems, manufactured by ZheJiang Decans Medical Devices Co., Ltd.. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K252930 · ZheJiang Decans Medical Devices Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
254d
Days
Class 2
Risk

K252930 is an FDA 510(k) clearance for the AQUA Laminoplasty Systems. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by ZheJiang Decans Medical Devices Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on May 27, 2026 after a review of 254 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all ZheJiang Decans Medical Devices Co., Ltd. devices

FDA 510(k) Submission Details - K252930

510(k) Number K252930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2025
Decision Date May 27, 2026
Days to Decision 254 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 122d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQW Device Classification - Class 2, Special Controls

Product Code NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 27
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K252930.
Curiteva Porous PEEK Laminoplasty System
K243137 · Curiteva, Inc. · Oct 2024
Vy Spine™ VyLam™ Laminoplasty System
K242784 · Vy Spine, LLC · Oct 2024
Vy Spine™ VyLam™ Laminoplasty System
K232471 · Vy Spine, LLC · Oct 2023
Curiteva Laminoplasty System
K231232 · Curiteva, Inc. · Jun 2023
Centerpiece Plate Fixation System
K212428 · Medtronic Sofamor Danek · Dec 2021
Hinged Laminoplasty System
K191927 · Life Spine, Inc. · Sep 2019