Cleared Traditional

K042635 - DENALI SPINE SYSTEM

K042635 is an FDA 510(k) clearance for DENALI SPINE 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 105-day FDA review.

K042635 · K2m, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2005
Decision
105d
Days
Class 2
Risk

K042635 is an FDA 510(k) clearance for the DENALI SPINE 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 January 10, 2005 after a review of 105 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 K2m, LLC devices

FDA 510(k) Submission Details - K042635

510(k) Number K042635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date January 10, 2005
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 374
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K042635.
CD HORIZON SPINAL SYSTEM
K050079 · Medtronic Sofamor Danek USA, Inc. · Feb 2005
ISSYS PEDICLE SCREW SYSTEM
K043522 · Custom Spine, Inc. · Jan 2005
MODIFICATION TO XIA SPINAL SYSTEM
K043473 · Stryker Spine · Jan 2005
GLAXY 3.2 SPINAL SYSTEM
K043020 · Medtronic Sofamor Danek · Jan 2005
VERTEX RECONSTRUCTION SYSTEM
K042789 · Medtronic Sofamor Danek · Dec 2004
MODIFICATION TO ALTIUS OCT SYSTEM
K043229 · Interpore Cross Intl. · Dec 2004