Cleared Special

K023922 - COAPT SYSTEMS ENDOTINE DEVICE

K023922 is an FDA 510(k) clearance for COAPT SYSTEMS ENDOTINE DEVICE, manufactured by Coapt Systems, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 25-day FDA review.

K023922 · Coapt Systems, Inc. · Orthopedic device
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Dec 2002
Decision
25d
Days
Class 2
Risk

K023922 is an FDA 510(k) clearance for the COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Coapt Systems, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on December 20, 2002 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Coapt Systems, Inc. devices

FDA 510(k) Submission Details - K023922

510(k) Number K023922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2002
Decision Date December 20, 2002
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 Orthopedic 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 K023922.
EBI DYNAFIX COMPRESSION BONE SCREW
K030706 · Ebi, L.P. · Mar 2003
STRYKER XCEL ANCHOR SYSTEM
K023013 · Stryker Endoscopy · Feb 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · Biomet Orthopedics, Inc. · Jan 2003
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · Howmedica Osteonics Corp. · Dec 2002
AAP CANNULATED SCREWS
K021233 · Aap Implantate AG · Dec 2002
MODULAR HEAD BONE SCREW
K022952 · Biomet, Inc. · Dec 2002