# K962552: EZ-6 Proximal Humeral Interamedullary Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Biodynamic Technologies, Inc.
- Decided: Sep 25, 1996 after 86 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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) Orthologic® OrthoNail® Humeral Intramedullary Fixation Device: named in the summary without a submission number
- (no number) Acumed™ Polarus® Proximal Humeral Fixation System: named in the summary without a submission number
- (no number) Applied Osteo Systems True/Flex™ Fixation Device: named in the summary without a submission number
- (no number) Howmedica Seidel™ Humeral Locking Nail System: named in the summary without a submission number

## Indications for use
The EZ-Fix™ Proximal Humeral Intramedullary Rod is an internal skeletal fixation device indicated for imtrameduliary use to stabilize fractures of the proximal humerus.

Source page: https://510kreport.com/device/K962552
Methodology: https://510kreport.com/methodology