# K022651: Hoffmann 30 Degree Pelvic Double Ball Joint

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 17, 2002 after 69 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) Hoffmann 5 Hole Ball Joint: named in the summary without a submission number

## Indications for use
The Hoffmann@30 Degree Pelvic Double Ball Joint is intended to be used with the components of the Hoffmann@External Fixation System, HoffmannO I1 External Fixation System, Monotube@ TRIAXTM External Fixation System and in conjunction with Apex@Pins. This device is used to provide stabilization of open andor 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. The indications for use of external fixation devices include: Bone fracture fixation Osteotomy Arthrodesis Correction of deformity Revision procedure where other treatments or devices have been unsuccessful Bone reconstruction procedures

Source page: https://510kreport.com/device/K022651
Methodology: https://510kreport.com/methodology