Cleared Traditional

LANX ANTERIOR CERVIAL PLATE SYSTEM (K040401) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040401 · Lanx, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
55d
Days
Class 2
Risk

K040401 is an FDA 510(k) clearance for the LANX ANTERIOR CERVIAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Lanx, LLC (Pleasant Hill, US). The FDA issued a Cleared decision on April 12, 2004 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lanx, LLC devices

Submission Details

510(k) Number K040401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date April 12, 2004
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 224
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K040401.
CD HORIZON SPINAL SYSTEM
K041460 · Medtronic Sofamor Danek USA, Inc. · Jul 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · Globus Medical, Inc. · Jun 2004
ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
K040017 · Aesculap, Inc. · May 2004
SYNTHES VENTROFIX MIS SYSTEM
K031100 · Synthes (Usa) · Mar 2004
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · Synthes (Usa) · Feb 2004
MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K032059 · Aesculap, Inc. · Jul 2003