# K031941: Hoffmann II Compact Baltimore Coupling

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 24, 2003 after 30 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 Compact Rod to Rod Coupling: named in the summary without a submission number

## Indications for use
The Hoffmann II Compact Baltimore Coupling is intended to be ysed with the components of the Hoffmann II Compact External Fixation System and in conjunction with the half pins or transfixing pins of the Hoffmann External Fixation System. It is intended to be used in the stabilization of open andor unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as I M rodding, casting, or other means of internal fixation.

Source page: https://510kreport.com/device/K031941
Methodology: https://510kreport.com/methodology