# K051049: Synthes (Usa) Low-Profile Wrist Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 13, 2005 after 79 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Orthofix Penning Wrist Fixator: named in the summary without a submission number
- (no number) Synthes (USA) Articulating Distal Radius System: named in the summary without a submission number
- (no number) Synthes (USA) 4.0 mm Adjustable Clamp for Distal Radius: named in the summary without a submission number

## Indications for use
The Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.

Source page: https://510kreport.com/device/K051049
Methodology: https://510kreport.com/methodology