# K973982: Orbital Reconstruction Plates

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Jan 12, 1998 after 84 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) TiMesh's Titanium Mesh Tilghman Orbit Liner: named in the summary without a submission number
- (no number) Synthes' Universal Orbital Floor Plate: named in the summary without a submission number

## Indications for use
The plates are intended for use in patients requiring craniofacial reconstruction of the internal orbit. These plates provide structure and support to the orbit walls and/or floor when anatomical reconstruction of the internal orbit is necessary.

Source page: https://510kreport.com/device/K973982
Methodology: https://510kreport.com/methodology