Cleared Special

K083020 - STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM

K083020 is an FDA 510(k) clearance for STRYKER SPINE REFLEX TRANSLATIONAL ANTE..., manufactured by Stryker Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 168-day FDA review.

K083020 · Stryker Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
168d
Days
Class 2
Risk

K083020 is an FDA 510(k) clearance for the STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Stryker Corp. (Allendale, US). The FDA issued a Cleared decision on March 26, 2009 after a review of 168 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K083020

510(k) Number K083020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2008
Decision Date March 26, 2009
Days to Decision 168 days
Submission Type Special
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
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 667
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K083020.
PIONEER LUMBAR PLATE SYSTEM
K090222 · Pioneer Surgical Technology · Apr 2009
MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
K090316 · Lanx, Inc. · Apr 2009
BLACK WIDOW ANTERIOR BUTTRESS PLATE
K081770 · Omni Surgical, L.P. · Apr 2009
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM
K083562 · Stryker Corp. · Mar 2009
NUVASIVE HELIX-T ACP SYSTEM
K083341 · Nuvasive, Inc. · Mar 2009
PACP
K083663 · Pioneer Surgical Technology · Feb 2009
K083020 · STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM
Download PDF FDA Summary Stryker Corp.