Cleared Traditional

K013196 - ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM

K013196 is an FDA 510(k) clearance for ASCEND SPINAL FIXATION SYSTEM WITH THE ..., manufactured by Spinal Innovations, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K013196 · Spinal Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
127d
Days
Class 2
Risk

K013196 is an FDA 510(k) clearance for the ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Spinal Innovations, LLC (Bartlett, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 127 days - within the typical 510(k) review window.

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 Innovations, LLC devices

FDA 510(k) Submission Details - K013196

510(k) Number K013196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2001
Decision Date January 30, 2002
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 368
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K013196.
MSD WIRE SYSTEM
K020426 · Medtronic Sofamor Danek, Inc. · Feb 2002
MODIFICATION TO PASS SPINAL SYSTEM
K020236 · Encore Orthopedics, Inc. · Feb 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · Medtronic Sofamor Danek · Feb 2002
BUTTERFLY PLATE FIXATION SYSTEM
K014267 · Medtronic Sofamor Danek, Inc. · Jan 2002
PASS SPINAL SYSTEM
K013442 · Encore Orthopedics, Inc. · Jan 2002
XIA SPINAL SYSTEM
K013823 · Howmedica Osteonics Corp. · Dec 2001