Cleared Traditional

MACS MODULAR ANTERIOR CONSTRUCT SYSTEM (K002824) - FDA 510(k) Clearance

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

K002824 · Aesculap, Inc. · Orthopedic device
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May 2001
Decision
239d
Days
Class 2
Risk

K002824 is an FDA 510(k) clearance for the MACS MODULAR ANTERIOR CONSTRUCT SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Aesculap, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on May 8, 2001 after a review of 239 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, Inc. devices

Submission Details

510(k) Number K002824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2000
Decision Date May 08, 2001
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
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 238
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K002824.
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K020650 · Howmedica Osteonics Corp. · Mar 2002
CODMAN SLIM-LOC SYSTEM
K013877 · Codman & Shurtleff, Inc. · Dec 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · Aesculap, Inc. · Nov 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · Howmedica Osteonics Corp. · Apr 2001
XIA SPINE SYSTEM
K002858 · Howmedica Osteonics Corp. · Oct 2000
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · Howmedica Osteonics Corp. · Jul 2000