Cleared Special

K023921 - JET-X HA COATED HALF PINS

K023921 is the FDA 510(k) clearance for JET-X HA COATED HALF PINS by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JDW) cleared through the Special 510(k) pathway after a 72-day FDA review.

K023921 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
72d
Days
Class 2
Risk

K023921 is an FDA 510(k) clearance for the JET-X HA COATED HALF PINS. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 5, 2003 after a review of 72 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K023921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2002
Decision Date February 05, 2003
Days to Decision 72 days
Submission Type Special
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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 52
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K023921.
ACUMED CLAVICLE SCREW SYSTEM
K083144 · Acumed, LLC · Jun 2009
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K040765 · Synthes (Usa) · Apr 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · Smith & Nephew, Inc. · Jan 2004
JET-X TIN COATED HALF PINS
K023134 · Smith & Nephew, Inc. · Oct 2002
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K021182 · Biomet, Inc. · May 2002
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
K020097 · Stryker Endoscopy · Mar 2002