# K972479: Alta Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Sep 11, 1997 after 72 days
- Product code: HRS (Plate, 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) Alta® Distal Fracture Plates: named in the summary without a submission number
- (no number) Alta® Channel Plates: named in the summary without a submission number

## Indications for use
This Alta® Plating System line extension includes plates that are intended to provided temporary stabilization of intra- and extra-articular fractures of the distal femur. Types of fractures include simple and comminuted fractures of the femoral condyles, and selected femoral supracondylar fractures. The plates are used in conjunction with cortical and cancellous bone screws. During healing, the plate provides a buttress for the protection of the fracture fragments. Once healing is complete, the plate will generally be removed.

Source page: https://510kreport.com/device/K972479
Methodology: https://510kreport.com/methodology