# K981070: 20-Hole Adaptation Plate

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 20, 1998 after 57 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 no predicate by number.

## Indications for use
The 20-Hole Adaptation Plate is used in the following indications: 1. comminuted fractures of the naso-ethmoidal infraorbital areas 2. comminuted fractures of the frontal sinus wall 3. orbital floor fractures

Source page: https://510kreport.com/device/K981070
Methodology: https://510kreport.com/methodology