Cleared Traditional

TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM (K964623) - FDA 510(k) Clearance

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

K964623 · Sofamor Danek USA,Inc. · Orthopedic device
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Feb 1997
Decision
80d
Days
Class 2
Risk

K964623 is an FDA 510(k) clearance for the TITANIUM CD HORIZON ANTERIOR SPINAL 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 February 6, 1997 after a review of 80 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sofamor Danek USA,Inc. devices

Submission Details

510(k) Number K964623 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 18, 1996
Decision Date February 06, 1997
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
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 K964623.
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
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
K953720 · Aesculap, Inc. · Nov 1995