# K962553: EZ-Fix Midshaft Humeral Intramedullary Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Biodynamic Technologies, Inc.
- Decided: Aug 28, 1996 after 58 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices 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® OrthoNall® Humeral Intramedullary Fixation Device: 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
- (no number) Howmedica Alta® Humeral Rod: named in the summary without a submission number

## Most influential descendants
- K980609: Segmental Defect Replacement System (1998), 5 descendants of its own
- K051965: Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System (2006), 3 descendants of its own
- K142451: OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System (2015), 1 descendant of its own
- K181026: OsteoBridge™ IDSF System (2018), 0 descendants of its own
- K101939: Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System (2010), 0 descendants of its own

## Indications for use
The EZ-Fix™ Midshaft Humeral Intramedullary Rod is an intemal skeletal fixation device indicated for intramedullary use to stabilize midshaft fractures of the humerus.

Source page: https://510kreport.com/device/K962553
Methodology: https://510kreport.com/methodology