Cleared Special

K020236 - MODIFICATION TO PASS SPINAL SYSTEM

K020236 is an FDA 510(k) clearance for MODIFICATION TO PASS SPINAL SYSTEM, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 22-day FDA review.

K020236 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2002
Decision
22d
Days
Class 2
Risk

K020236 is an FDA 510(k) clearance for the MODIFICATION TO PASS SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on February 14, 2002 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K020236

510(k) Number K020236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2002
Decision Date February 14, 2002
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 282
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K020236.
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · United States Surgical, A Division of Tyco Healthc · Apr 2002
ENDIUS SPINAL FIXATION SYSTEM
K014090 · Endius, Inc. · Mar 2002
MSD WIRE SYSTEM
K020426 · Medtronic Sofamor Danek, Inc. · Feb 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · Medtronic Sofamor Danek · Feb 2002
BUTTERFLY PLATE FIXATION SYSTEM
K014267 · Medtronic Sofamor Danek, Inc. · Jan 2002
PASS SPINAL SYSTEM
K013442 · Encore Orthopedics, Inc. · Jan 2002