# K091051: Bollard Miniplate Skeletal Anchorage System

- Pathway: 510(k) (Traditional)
- Applicant: Tita-Link
- Decided: Dec 8, 2009 after 239 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.
1 later device descends from it; 1 cites it directly.
0 of 25 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 2.
- K041651: Stryker Leibinger Skeletal Anchoring System, Stryker Leibinger (2004) Summary page 2.

## Most influential descendants
- K173623: Anchor plate (2018), 0 descendants of its own

## Indications for use
The subject devices are intended to be placed in the mouth for use as an anchor in orthodontic procedures.

Source page: https://510kreport.com/device/K091051
Methodology: https://510kreport.com/methodology