# K023921: Jet-X HA Coated Half Pins

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 5, 2003 after 72 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 27 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953397 (1995). 2 ancestors in all.
50 later devices descend from it; 6 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023134: Jet-X Tin Coated Half Pins, Smith & Nephew, Inc. (2002)

## Most influential descendants
- K033289: Modification to Jet-X HA Coated Half Pins (2004), 49 descendants of its own
- K050849: HA Coated Lag Screw (2005), 34 descendants of its own
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation (2013), 33 descendants of its own
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own

## Recalls of this device
- Apr 13, 2012 · Not classified · Z-1727-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1744-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1736-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1737-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1770-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1741-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1739-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1742-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1743-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1771-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1728-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1738-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1733-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1768-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1732-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1731-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1725-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1745-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1730-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1769-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1726-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1734-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1729-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1740-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1746-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1767-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
- Apr 13, 2012 · Not classified · Z-1772-2012: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.

## Indications for use
The Jet-X HA Coated Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.

Source page: https://510kreport.com/device/K023921
Methodology: https://510kreport.com/methodology