# K033483: KLS-Martin Ortho Anchorage System

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jan 15, 2004 after 72 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: 2 generations back to K925771 (1993). 8 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971297: Centre-Drive Drill-Free Screw, KLS-Martin L.P. (1997) Summary page 1.
- K980460: Onplant Orthodontic System, Nobel Biocare Uas, Inc. (1998) Summary page 1.

## Most influential descendants
- K061397: Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model 454-91001,454-91002 and 1.2/1.5MM X 6,8,10MM, M (2006), 6 descendants of its own
- K080074: Ace Surigical Tru-Fix Implant System, Model 454-180X-XX (2008), 5 descendants of its own
- K042573: KLS Martin Drill-Free MMF Screw (2004), 4 descendants of its own
- K041651: Stryker Leibinger Skeletal Anchoring System (2004), 4 descendants of its own
- K083432: Drill Free MMF Screw (2009), 3 descendants of its own

## Indications for use
The KLS-Martin Ortho Anchorage System are screws intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.

Source page: https://510kreport.com/device/K033483
Methodology: https://510kreport.com/methodology