Cleared Traditional

K212428 - Centerpiece Plate Fixation System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212428 · Medtronic Sofamor Danek · Orthopedic device
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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

Submission Details

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.

Device Classification

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.