Cleared Traditional

K014090 - ENDIUS SPINAL FIXATION SYSTEM

K014090 is an FDA 510(k) clearance for ENDIUS SPINAL FIXATION SYSTEM, manufactured by Endius, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K014090 · Endius, Inc. · Orthopedic device
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Mar 2002
Decision
90d
Days
Class 2
Risk

K014090 is an FDA 510(k) clearance for the ENDIUS SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Endius, Inc. (Plainville, US). The FDA issued a Cleared decision on March 11, 2002 after a review of 90 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 Endius, Inc. devices

FDA 510(k) Submission Details - K014090

510(k) Number K014090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2001
Decision Date March 11, 2002
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K014090.
OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM
K021009 · Spinal Concepts, Inc. · Jun 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K020709 · Medtronic Sofamor Danek · May 2002
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · United States Surgical, A Division of Tyco Healthc · Apr 2002
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