Cleared Traditional

SMISSON STABILIZATION SYSTEM (K021979) - FDA 510(k) Clearance

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

K021979 · Smisson-Cartledge · Orthopedic device
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Jun 2003
Decision
375d
Days
Class 2
Risk

K021979 is an FDA 510(k) clearance for the SMISSON STABILIZATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Smisson-Cartledge (Irvine, US). The FDA issued a Cleared decision on June 27, 2003 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Elevated predicate reliance profile. 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 Smisson-Cartledge devices

Submission Details

510(k) Number K021979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2002
Decision Date June 27, 2003
Days to Decision 375 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 122d · This submission: 375d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 239
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K021979.
CD HORIZON SPINAL SYSTEM
K032265 · Medtronic Sofamor Danek · Aug 2003
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059 · Aesculap, Inc. · Jul 2003
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
K031276 · Synthes (Usa) · Jul 2003
SYNTHES ANTERIOR CSLP SYSTEM
K030866 · Synthes (Usa) · Apr 2003
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327 · Medtronic Sofamor Danek · Feb 2003
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · Synthes (Usa) · Nov 2002