# K053349: Hoffmann II Rod to Wire Coupling

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 9, 2005 after 7 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) Hoffmann® II External Fixation System: named in the summary without a submission number
- (no number) Hoffmann® II Hybrid Frame System: named in the summary without a submission number

## Indications for use
The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex™ Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX™ External Fixation System. This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation.

Source page: https://510kreport.com/device/K053349
Methodology: https://510kreport.com/methodology