# K993004: Alta Fully Threaded Cross-Locking 5.0 MM Screw

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 6, 1999 after 29 days
- Product code: JDS (Nail, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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) Osteo System Locking Screw: named in the summary without a submission number

## Indications for use
The Alta® Fully Threaded Cross-Locking 5.0mm Screw is indicated for use in fractures requiring static and dynamic locking applications which include the Intramedullary Rods in the Alta® Femoral and Alta® Tibial /Humeral Rod Systems. Specifically, these screws will be used with the Alta® Femoral Locking IM Rod (K850441 & K822266), the Alta® CFX Reconstruction Rod (K926232, K935295, & K960524), the Alta® Tibial/Humeral IM Rod (K884500, K890936, and K954554), and the Alta® Retrograde Rod (K9872108).

Source page: https://510kreport.com/device/K993004
Methodology: https://510kreport.com/methodology