# K051798: Osteomed Orthodontic Anchor Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Apr 7, 2006 after 276 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954385 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040891: KLS Martin Ortho Anchorage System (Plates), KLS-Martin L.P. (2004) Summary page 1.
- K041651: Stryker Leibinger Skeletal Anchoring System, Stryker Leibinger (2004) Summary page 1.

## Indications for use
Intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures. It is used temporarily and is removed after orthodontic treatment has been completed. Plates, screws, and pilot drills are intended for single use only.

Source page: https://510kreport.com/device/K051798
Methodology: https://510kreport.com/methodology