# K033112: Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NS

- Pathway: 510(k) (Traditional)
- Applicant: Hand Biomechanics Lab, Inc.
- Decided: Nov 5, 2003 after 36 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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
Longest line of descent: 2 generations back to K842493 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984442: Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147, Hand Biomechanics Lab, Inc. (1999) Summary page 1.

## Indications for use
Fracture reduction and external fixation for treatment of distal radius fractures.

Source page: https://510kreport.com/device/K033112
Methodology: https://510kreport.com/methodology