Cleared Special

ISOLA POLYAXIAL WASHER (K013441) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013441 · Depuyacromed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
30d
Days
Class 2
Risk

K013441 is an FDA 510(k) clearance for the ISOLA POLYAXIAL WASHER. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 30 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 Depuyacromed devices

Submission Details

510(k) Number K013441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2001
Decision Date November 16, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 99
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K013441.
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · United States Surgical, A Division of Tyco Healthc · Apr 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · Medtronic Sofamor Danek · Feb 2002
XIA SPINAL SYSTEM
K013823 · Howmedica Osteonics Corp. · Dec 2001
XIA STAINLESS STEEL SYSTEM
K012870 · Howmedica Osteonics Corp. · Sep 2001
SYNTHES CERVIFIX SYSTEM
K011969 · Synthes (Usa) · Jul 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · Medtronic Sofamor Danek USA, Inc. · May 2001