Cleared Traditional

K040096 - SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM

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

K040096 · Spinal Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K040096

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.

KWP Device Classification - Class 2, Special Controls

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 387
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K040096.
CORAL SPINAL SYSTEM
K041592 · Theken Surgical · 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