# K963432: Guide Wires for Cannulated Screws

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Biosystems, Ltd.
- Decided: Nov 13, 1996 after 75 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
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) Synthes guidewires: named in the summary without a submission number

## Indications for use
Both function in conjunction with a cannulated bone screw used as internal fixation for the carpel, tarsal, metatarsal, metacarpal, and phaianges of the hand and foot.

Source page: https://510kreport.com/device/K963432
Methodology: https://510kreport.com/methodology