# K984305: Zeta Multizone Locking Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Feb 1, 1999 after 61 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) Alta IM Rod System: named in the summary without a submission number
- (no number) Locking Nail System: named in the summary without a submission number
- (no number) Gamma Locking Nail System: named in the summary without a submission number

## Indications for use
The Zeta MultiZone Humeral Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the humerus. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.

Source page: https://510kreport.com/device/K984305
Methodology: https://510kreport.com/methodology