# K970911: Lee Plate

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Leibinger, Inc.
- Decided: Apr 11, 1997 after 30 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
Longest line of descent: 1 generation back to K862534 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862534: Paulus Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 4.

## Indications for use
The Lee Plate is intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). The basic operational principle is to provide fixation/stabilization of an anterior mandibular bone segment that is freed during a corrective osteotomy procedure.

Source page: https://510kreport.com/device/K970911
Methodology: https://510kreport.com/methodology