# K042458: A.M. Surgical CPF Distal Radial External Cross Pin Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: A.M. Surgical, Inc.
- Decided: Oct 7, 2004 after 27 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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 K003240 (2000). 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)
- K020905: NBX - Non-Bridging External Fixator, Biomet Orthopedics, Inc. (2002) Summary page 1.

## Indications for use
The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM roding, casting, and other means of external fixation.

Source page: https://510kreport.com/device/K042458
Methodology: https://510kreport.com/methodology