# K960524: Alta CFX IM Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Mar 22, 1996 after 46 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
Longest line of descent: 1 generation back to K813371 (1982). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926232: Alta CFX Rod System, Howmedica Corp. (1993) Summary page 1.
- K850441: Mec Intramedullary Rod, Pfizer, Inc. (1985) Summary page 1.
- K813371: Grosse and Kempf Locking Nail Sys., Howmedica Corp. (1982) Summary page 1.
- (no number) AIM Femoral System: named in the summary without a submission number
- (no number) ZMS Recon Nail System: named in the summary without a submission number

## Most influential descendants
- K970257: Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian Fractures (1997), 0 descendants of its own
- K963398: Alta Fully Threaded Cross-Locking Screws (1996), 0 descendants of its own

## Indications for use
These devices are intended to be used for the fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, and comminuted proximal femoral shaft fractures, as well as for temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.

Source page: https://510kreport.com/device/K960524
Methodology: https://510kreport.com/methodology