Cleared Special

K023921 - JET-X HA COATED HALF PINS

K023921 is an FDA 510(k) clearance for JET-X HA COATED HALF PINS, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K023921

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.

JDW Device Classification - Class 2, Special Controls

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 93
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K023921.
TARAS THREADED FIXATION PIN
K032532 · Union Surgical, LLC · Oct 2003
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
K031154 · Sintea Biotech, Inc. · Jun 2003
KMEDIC EXTERNAL FIXATION DEVICES
K030336 · Teleflex Medical Group · Mar 2003
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
K023921 · JET-X HA COATED HALF PINS
Download PDF FDA Summary Smith & Nephew, Inc.