Cleared Traditional

K021039 - BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM

K021039 is an FDA 510(k) clearance for BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM, manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K021039 · Depuyacromed · Orthopedic device
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Dec 2002
Decision
254d
Days
Class 2
Risk

K021039 is an FDA 510(k) clearance for the BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on December 11, 2002 after a review of 254 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 Depuyacromed devices

FDA 510(k) Submission Details - K021039

510(k) Number K021039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date December 11, 2002
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
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 624
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K021039.
ORIA CERVICAL PLATES
K023377 · Ortho Tec, LLC · Mar 2003
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327 · Medtronic Sofamor Danek · Feb 2003
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K024326 · Spinal Concepts, Inc. · Jan 2003
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS
K022798 · Corin USA · Nov 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · Synthes (Usa) · Nov 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · Spinal Concepts, Inc. · Oct 2002