Cleared Traditional

SPIRAL RADIUS 90-D RODDING SYSTEM (K020134) - FDA 510(k) Clearance

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

K020134 · United States Surgical, A Division of Tyco Healthc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
90d
Days
Class 2
Risk

K020134 is an FDA 510(k) clearance for the SPIRAL RADIUS 90-D RODDING SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on April 15, 2002 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K020134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2002
Decision Date April 15, 2002
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.

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 98
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K020134.
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K021061 · Medtronic Sofamor Danek · Jul 2002
TSRH SPINAL SYSTEM
K021170 · Medtronic Sofamor Danek USA, Inc. · Jul 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K020709 · Medtronic Sofamor Danek · May 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