# K984442: Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147

- Pathway: 510(k) (Traditional)
- Applicant: Hand Biomechanics Lab, Inc.
- Decided: Feb 12, 1999 after 60 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K842493 (1985). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842493: Agee External Fixator, The Hand Biomechanics Research Laboratory (1985) Summary page 1.

## Most influential descendants
- K033112: Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NS (2003), 0 descendants of its own
- K030519: Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNS (2003), 0 descendants of its own

## Recalls of this device
- Sep 14, 2016 · Class II · Z-0136-2017: A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the len

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

Source page: https://510kreport.com/device/K984442
Methodology: https://510kreport.com/methodology