# K983339: Osteo Dynatroc Proximal Femoral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Oct 27, 1998 after 34 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) Synthes PFN: named in the summary without a submission number
- (no number) Richards IMHS Nail: named in the summary without a submission number
- (no number) Howmedica Gamma Locking Nail: named in the summary without a submission number

## Indications for use
The Osteo DynaTroc™ Proximal Femoral Nail is indicated for proximal femoral fracture fixation, which includes the following: Intertrochanteric fractures Pertrochanteric fractures High subtrochanteric fractures

Source page: https://510kreport.com/device/K983339
Methodology: https://510kreport.com/methodology