# K033289: Modification to Jet-X HA Coated Half Pins

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 13, 2004 after 91 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953397 (1995). 3 ancestors in all.
49 later devices descend from it; 4 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)
- K023921: Jet-X HA Coated Half Pins, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own

## 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/K033289
Methodology: https://510kreport.com/methodology
