# K010458: The Maestro System

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: May 10, 2001 after 83 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
No predicates in its family tree.
337 later devices descend from it; 8 cite it directly.
0 of 338 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020133: Modification to the Maestro System (2002), 334 descendants of its own
- K020645: Modification to the Maestro System (2002), 333 descendants of its own
- K022795: Modification to the Maestro System (2002), 332 descendants of its own
- K030463: Modification to the Maestro System (2003), 331 descendants of its own
- K032351: The Maestro System 3.0MM Diameter Implant (2003), 313 descendants of its own

Source page: https://510kreport.com/device/K010458
Methodology: https://510kreport.com/methodology