# 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

- Pathway: 510(k) (Traditional)
- Applicant: Ace Surgical Supply Co., Inc.
- Decided: Aug 16, 2006 after 89 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: 4 generations back to K894844 (1990). 18 ancestors in all.
6 later devices descend 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)
- K951392: Miniboneplate System, Ace Surgical Supply Co., Inc. (1995) Summary page 1.
- K033483: KLS-Martin Ortho Anchorage System, KLS-Martin L.P. (2004) Summary page 1.
- K031936: Osteomed Orthodontic Screw System, Osteomed LP (2004) Summary page 1.

## Most influential descendants
- K080074: Ace Surigical Tru-Fix Implant System, Model 454-180X-XX (2008), 5 descendants of its own
- K100779: Sustain Space Maintenance System (2010), 2 descendants of its own
- K182881: Bone Screw, Bone Tack (2019), 1 descendant of its own
- K110259: Architex Space Maintenance System (2011), 1 descendant of its own
- K251569: Bone Screw (2025), 0 descendants of its own

## Indications for use
The ACE Surgical Orthodontic Bone Screw System is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.

Source page: https://510kreport.com/device/K061397
Methodology: https://510kreport.com/methodology