# K020311: Clearview Wrist Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Rigid FX Orthopedics, Incorporated
- Decided: Apr 29, 2002 after 90 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: 3 generations back to K970713 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992970: Digit Widget, Hand Biomechanics Lab, Inc. (1999) Summary page 1.
- K984498: Synthes (Usa) Articulating Distal Radius (Adrf) System, Synthes (Usa) (1999) Summary page 1.
- K993649: Ebi Xfix DFS Wristfix System, Ebi, L.P. (1999) Summary page 1.

## Indications for use
The ClearView™ Wrist Fixator is indicated for single use for fixation of distal fractures in upper extremity applications. This device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Common fractures indicated for this use: fractures of the wrist with ligamentous instability comminuted intra-articular radius fractures post-traumatic reconstruction for joint stiffness Colles Fracture distal radius fractures (Types B and C) Frykman Type 1L, I'V, VII and VIII radius fractures any wrist fracture requiring distraction

Source page: https://510kreport.com/device/K020311
Methodology: https://510kreport.com/methodology