Cleared Traditional

K052404 - DENALI DEFORMITY SYSTEM

K052404 is an FDA 510(k) clearance for DENALI DEFORMITY SYSTEM, manufactured by K2m, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K052404 · K2m, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
264d
Days
Class 2
Risk

K052404 is an FDA 510(k) clearance for the DENALI DEFORMITY SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by K2m, LLC (Leesburg, US). The FDA issued a Cleared decision on May 23, 2006 after a review of 264 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 K2m, LLC devices

FDA 510(k) Submission Details - K052404

510(k) Number K052404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2005
Decision Date May 23, 2006
Days to Decision 264 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
142d slower than avg
Panel avg: 122d · This submission: 264d
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 375
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K052404.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591 · Medtronic Sofamor Danek, Inc. · Sep 2006
SYNTHES OC FUSION SYSTEM
K053418 · Synthes Spine Co.Lp · Sep 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579 · Medtronic Sofamor Danek · Aug 2006
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K060683 · Endius, Inc. · Apr 2006
BASIS SPINAL SYSTEM
K060081 · Medtronic Sofamor Danek · Feb 2006
SOLANAS POSTERIOR STABILIZATION SYSTEM
K052201 · Alphatec Spine, Inc. · Nov 2005