# K033145: Hoffmann II Pelvic Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 5, 2003 after 36 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) 30 Degree Pelvic Double Ball Joint: named in the summary without a submission number

## Indications for use
The Hoffmann@I1 Pelvic Clamp is an external fixation frame component for use with the components of the HoffmannO External Fixation System, Hoffmann@I1 External Fixation System, Monotube@TRIAXTUExternal Fixation System and in conjunction with ApexQ Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

Source page: https://510kreport.com/device/K033145
Methodology: https://510kreport.com/methodology