# K984498: Synthes (Usa) Articulating Distal Radius (Adrf) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 18, 1999 after 63 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: 1 generation back to K942906 (1994). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963618: Synthes Simple Small External Fixator (Ssef), Synthes (Usa) (1996) Summary page 1.
- K942906: Agee-Wristjack Pre-Drill Kit, Hand Biomechanics Lab, Inc. (1994) Summary page 1.
- K982982: Mini-Fixator for Colles Fractures, Biomet, Inc. (1998) Summary page 1.

## Most influential descendants
- K012294: Wristore Fixator (2002), 3 descendants of its own
- K042761: Wristore Distal Radius Fracture Fixator, 4600 Series (2004), 1 descendant of its own
- K101338: Newfix External Fixation System (2011), 0 descendants of its own
- K052498: Fragment Specific Fixator (2005), 0 descendants of its own
- K020311: Clearview Wrist Fixator (2002), 0 descendants of its own

## Indications for use
Synthes Articulating Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.

Source page: https://510kreport.com/device/K984498
Methodology: https://510kreport.com/methodology