Cleared Traditional

COAPT ENDOTINE CHIN 3.5 DEVICE (K033524) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033524 · Coapt Systems, Inc. · General & Plastic Surgery device
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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

Submission Details

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.

Device Classification

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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K033524.
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331 · Smith & Nephew, Inc. · Apr 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · United States Surgical, A Division of Tyco Healthc · Mar 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · Synthes (Usa) · Mar 2004
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · Biomet, Inc. · Nov 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B
K032098 · Arthrex, Inc. · Oct 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945 · Arthrex, Inc. · Sep 2003