# K963398: Alta Fully Threaded Cross-Locking Screws

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Oct 10, 1996 after 42 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K813371 (1982). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850441: Mec Intramedullary Rod, Pfizer, Inc. (1985) Summary page 1.
- K922266: Alta Femoral Intramedullary Rod System, Add Sizes, Howmedica Corp. (1992) Summary page 1.
- K926232: Alta CFX Rod System, Howmedica Corp. (1993) Summary page 1.
- K935295: Alta Femoral Intramedullary Rods/CFX Rods Modification, Howmedica Corp. (1994) Summary page 1.
- K960524: Alta CFX IM Rod System, Howmedica Corp. (1996) Summary page 1.
- K884500: Alta Non-Reamed Tibial Rod, Howmedica Corp. (1989) Summary page 1.
- K890936: Alta Hollow Tibial Rods, Howmedica Corp. (1989) Summary page 1.
- K954554: Alta Tibial/Humeral Rod, Howmedica Corp. (1995) Summary page 1.
- (no number) Uniflex Tibial Nail System: named in the summary without a submission number
- (no number) Retrograde Femoral Nail System: named in the summary without a submission number
- (no number) ZMS Intramedullary Recon Nail: named in the summary without a submission number

## Indications for use
The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal.

Source page: https://510kreport.com/device/K963398
Methodology: https://510kreport.com/methodology