Cleared Traditional

K033524 - COAPT ENDOTINE CHIN 3.5 DEVICE

K033524 is an FDA 510(k) clearance for COAPT ENDOTINE CHIN 3.5 DEVICE, manufactured by Coapt Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code HWC cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K033524 · Coapt Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
41d
Days
Class 2
Risk

K033524 is an FDA 510(k) clearance for the COAPT ENDOTINE CHIN 3.5 DEVICE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Coapt Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on December 18, 2003 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 888.3040 - the FDA general and plastic surgery device 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 Coapt Systems, Inc. devices

FDA 510(k) Submission Details - K033524

510(k) Number K033524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2003
Decision Date December 18, 2003
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 641
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K033524.
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · Synthes (Usa) · Mar 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · Acumed, LLC · Jan 2004
BIOANCHOR WITH DISPOSABLE DRIVER
K033804 · Linvatec Corp. · Dec 2003
LORENZ STERNAL CLOSURE SYSTEM
K033740 · Walter Lorenz Surgical, Inc. · Dec 2003
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K033252 · Stryker Endoscopy · Nov 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · Biomet, Inc. · Nov 2003