Cleared Traditional

K212428 - Centerpiece Plate Fixation System

K212428 is an FDA 510(k) clearance for Centerpiece Plate Fixation System, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K212428 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
131d
Days
Class 2
Risk

K212428 is an FDA 510(k) clearance for the Centerpiece Plate Fixation System. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on December 13, 2021 after a review of 131 days - within the typical 510(k) review window.

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 Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K212428

510(k) Number K212428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2021
Decision Date December 13, 2021
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
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 28
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K212428.
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
Hinged Laminoplasty System
K191927 · Life Spine, Inc. · Sep 2019
NuVasive® Camber Laminoplasty System
K191169 · Nu Vasive, Incorporated · Jul 2019
Life Spine Laminoplasty System
K181717 · Life Spine, Inc. · Oct 2018