# K983419: Hoffmann II Miami Post

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Nov 25, 1998 after 57 days
- Product code: HRS (Plate, Fixation, Bone)
- 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) Howmedica Monticelli/Spinelli Sliding Clamp (with articulating coupling): named in the summary without a submission number
- (no number) Synthes Ring-to-Rod Clamp: named in the summary without a submission number
- (no number) Zimmer Torus Ring-to-Rod Clamp: named in the summary without a submission number

## Indications for use
The Hoffmann® Il Miami Post is used for treating fractures, performing arthrodeses, and distraction osteogenesis of long bones, i.e., tibia, femur and humerus. It also provides 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. It is to be used to provide a hybrid construct combing any 6mm external fixation ring to the Hoffmann® Il rod to rod and pin to rod clamps. The post will extend the use of the Hoffmann® Il External Fixation System to Hybrid frames that utilize circular rings with 6mm mounting holes.

Source page: https://510kreport.com/device/K983419
Methodology: https://510kreport.com/methodology