# K041651: Stryker Leibinger Skeletal Anchoring System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger
- Decided: Sep 30, 2004 after 105 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: 4 generations back to K954385 (1996). 20 ancestors in all.
4 later devices descend from it; 3 cite 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)
- K033483: KLS-Martin Ortho Anchorage System, KLS-Martin L.P. (2004) Summary page 1.
- K022185: Universal CMF System, Stryker Instruments (2002) Summary page 1.

## Most influential descendants
- K091051: Bollard Miniplate Skeletal Anchorage System (2009), 1 descendant of its own
- K173623: Anchor plate (2018), 0 descendants of its own
- K063386: Lorenz Orthodontic Anchorage System (2007), 0 descendants of its own
- K051798: Osteomed Orthodontic Anchor Plating System (2006), 0 descendants of its own

## Indications for use
The Stryker Leibinger Skeletal Anchoring System is a plating system intended to be placed in the mouth, for use as an anchor in orthodontic procedures.

Source page: https://510kreport.com/device/K041651
Methodology: https://510kreport.com/methodology