Cleared Traditional

K100243 - QUINTEX CERVICAL PLATING SYSTEM

K100243 is an FDA 510(k) clearance for QUINTEX CERVICAL PLATING SYSTEM, manufactured by Aesculap Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K100243 · Aesculap Implant Systems, LLC · Orthopedic device
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Sep 2010
Decision
218d
Days
Class 2
Risk

K100243 is an FDA 510(k) clearance for the QUINTEX CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Aesculap Implant Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on September 2, 2010 after a review of 218 days - an extended review 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: 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 Aesculap Implant Systems, LLC devices

FDA 510(k) Submission Details - K100243

510(k) Number K100243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2010
Decision Date September 02, 2010
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

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 479
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K100243.
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820 · Alphatec Spine, Inc. · Nov 2010
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
K101848 · Spinal Elements, Inc. · Oct 2010
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
K102265 · Ldr Spine USA · Sep 2010
ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
K101255 · Alphatec Spine, Inc. · Jul 2010
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K100708 · Pioneer Surgical Technology · Jun 2010
MAMBO, MODEL CS 18XX-XX
K090861 · Ulrich GmbH & Co. KG · May 2010