Cleared Traditional

K090354 - LAMINOPLASTY PLATING SYSTEM

K090354 is an FDA 510(k) clearance for LAMINOPLASTY PLATING SYSTEM, manufactured by Aesculap Implant System, Inc.. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K090354 · Aesculap Implant System, Inc. · Orthopedic device
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May 2009
Decision
90d
Days
Class 2
Risk

K090354 is an FDA 510(k) clearance for the LAMINOPLASTY PLATING SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Aesculap Implant System, Inc. (Center Valley, US). The FDA issued a Cleared decision on May 12, 2009 after a review of 90 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 Aesculap Implant System, Inc. devices

FDA 510(k) Submission Details - K090354

510(k) Number K090354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2009
Decision Date May 12, 2009
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 25
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K090354.
LAMINOPLASY PLATING SYSTEM
K103284 · Aesculap Implant Systems, Inc. · Dec 2010
MOUNTAINEER LAMINOPLASTY SYSTEM
K091994 · Depuy Spine, Inc. · Jan 2010
LAMINOPLASTY FIXATION SYSTEM
K091623 · Nuvasive, Inc. · Oct 2009
RELIEVE LAMINOPLASTY FIXATION SYSTEM
K080664 · Globus Medical, Inc. · Jul 2008
CENTERPIECE PLATE FIXATION SYSTEM
K050082 · Medtronic Sofamor Danek, Inc. · Jun 2005
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
K043338 · Blackstone Medical, Inc. · Feb 2005