# K063386: Lorenz Orthodontic Anchorage System

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Feb 9, 2007 after 93 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- 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). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 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.
- K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System, Walter Lorenz Surgical, Inc. (1995) Summary page 1.
- K983728: Lorenz Imf Screw, Walter Lorenz Surgical, Inc. (1999) Summary page 1.
- K040983: Lorenz Self-Drilling Imf Screw, Walter Lorenz Surgical, Inc. (2004) Summary page 1.

## Indications for use
The Lorenz Orthodontic Anchorage System implants are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.

Source page: https://510kreport.com/device/K063386
Methodology: https://510kreport.com/methodology