# K080074: Ace Surigical Tru-Fix Implant System, Model 454-180X-XX

- Pathway: 510(k) (Special)
- Applicant: Ace Surgical Supply Co., Inc.
- Decided: Feb 14, 2008 after 34 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 K894844 (1990). 19 ancestors in all.
5 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)
- 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, Ace Surgical Supply Co., Inc. (2006) Summary page 1.
- K951392: Miniboneplate System, Ace Surgical Supply Co., Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K120271: Artisan Space Maintenance System (2012), 0 descendants of its own

## Indications for use
ACE Tru-FIX™ Implant System is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

Source page: https://510kreport.com/device/K080074
Methodology: https://510kreport.com/methodology