# K981309: Osteo I-C Humeral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jun 22, 1998 after 73 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) Biomet Uniflex™ Humeral Nail System: named in the summary without a submission number
- (no number) Synthes Titanium Solid Nail System: named in the summary without a submission number

## Indications for use
The use of the Osteo I-C humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures. The use of this system is indicated for diagonal and short oblique fractures of the humeral diaphysis as well as fractures of the metaphyseal and some comminuted humeral fractures. The Osteo I-C Humeral Nail System is intended for single use only. Indications: > Fractures of the humeral shaft > Non-unions - Malalignments > Pathologic humeral fractures . Impending pathologic humeral fractures

Source page: https://510kreport.com/device/K981309
Methodology: https://510kreport.com/methodology