Cleared Traditional

K040096 - SPINAL CONCEPTS

K040096 is the FDA 510(k) clearance for SPINAL CONCEPTS by Spinal Concepts, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K040096 · Spinal Concepts, Inc. · Orthopedic device
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Jul 2004
Decision
163d
Days
Class 2
Risk

K040096 is an FDA 510(k) clearance for the SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 163 days - an extended review cycle.

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 Spinal Concepts, Inc. devices

Submission Details

510(k) Number K040096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date July 01, 2004
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
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 272
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K040096.
ST360 SPINAL FIXATION SYSTEM
K041925 · Zimmer Spine, Inc. · Sep 2004
CD HORIZON SPINAL SYSTEM
K041862 · Medtronic Sofamor Danek · Sep 2004
EXPEDIUM SPINE SYSTEM
K041119 · Depuy Spine, Inc. · Jul 2004
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT
K041449 · Interpore Cross Intl. · Jul 2004
MODIFICATION TO TSRH SPINAL SYSTEM
K041282 · Medtronic Sofamor Danek, Inc. · Jun 2004
ALTIUS OCT SYSTEM
K033961 · Interpore Cross Intl. · Apr 2004