# K953397: Hex-Fix Field Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Oct 31, 1995 after 103 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
57 later devices descend from it; 5 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023134: Jet-X Tin Coated Half Pins (2002), 51 descendants of its own
- K023921: Jet-X HA Coated Half Pins (2003), 50 descendants of its own
- 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

Source page: https://510kreport.com/device/K953397
Methodology: https://510kreport.com/methodology