Cleared Traditional

DUAL ROD ANTERIOR FIXATOR SYSTEM (K963780) - FDA 510(k) Clearance

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

K963780 · Sofamor Danek USA,Inc. · Orthopedic device
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Jul 1997
Decision
313d
Days
Class 2
Risk

K963780 is an FDA 510(k) clearance for the DUAL ROD ANTERIOR FIXATOR SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on July 30, 1997 after a review of 313 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 Sofamor Danek USA,Inc. devices

Submission Details

510(k) Number K963780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1996
Decision Date July 30, 1997
Days to Decision 313 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 122d · This submission: 313d
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 K963780.
DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM
K973060 · Depuy, Inc. · Nov 1997
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K971883 · Synthes (Usa) · Oct 1997
SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
K970048 · Synthes (Usa) · Aug 1997
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K964416 · Synthes (Usa) · Mar 1997
DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM
K962486 · Depuy, Inc. · Dec 1996
CODMAN ANTERIOR CERVICAL PLATE SYSTEM
K953730 · Johnson & Johnson Professionals, Inc. · Nov 1995