# K972108: Alta Intramedullary Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Aug 12, 1997 after 68 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) Howmedica's Alta® IM Rod System: named in the summary without a submission number
- (no number) Alta® CFX Reconstruction Rod: named in the summary without a submission number
- (no number) Richard’s TriMax Nail System: named in the summary without a submission number
- (no number) ACE Medical's ART™ Femoral Nail System: named in the summary without a submission number
- (no number) Biomet's Retrograde Femoral Nail: named in the summary without a submission number

## Most influential descendants
- K022632: Sign IM Nail (2002), 2 descendants of its own
- K163589: SIGN IM Nail (2017), 0 descendants of its own
- K152757: SIGN Hip Construct (SHC) (2015), 0 descendants of its own

## Indications for use
The Alta® IM Rod System includes rods that are intended to provided temporary stabilization of femoral fractures. The new Alta rods are intended for use in stabilizing various types of fractures, osteotomies, malunions, and nonunions of the proximal, middle, and distal portions of the femur. They can be used in procedures such as femoral reconstruction, bone lengthening/shortening, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures and knee fusions. The rods are inserted into the intramedullary canal using either an antegrade or a retrograde approach.

Source page: https://510kreport.com/device/K972108
Methodology: https://510kreport.com/methodology