# K982602: Retrograde Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Sep 14, 1998 after 49 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) Howmedica Alta® IM Rod System: named in the summary without a submission number
- (no number) Synthes Ti DFN System: named in the summary without a submission number
- (no number) ACE Medical ART™ Femoral Nail System: named in the summary without a submission number

## Indications for use
The Alta® IM Rod System consists of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral fractures. The new Retrograde Rod is intended for stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur. The rods can be inserted with or without reaming and can be statically or dynamically locked.

Source page: https://510kreport.com/device/K982602
Methodology: https://510kreport.com/methodology