# K022795: Modification to the Maestro System

- Pathway: 510(k) (Special)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Aug 30, 2002 after 7 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K960026 (1996). 7 ancestors in all.
332 later devices descend from it; 2 cite it directly.
0 of 340 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010458: The Maestro System, BioHorizons Implant Systems, Inc. (2001) Summary page 1.
- K960026: Biohorizons Dental Implant System, BioHorizons Implant Systems, Inc. (1996) Summary page 1.
- K964330: Biohorizons Dental Implant System (Name Subject to Change), BioHorizons Implant Systems, Inc. (1997) Summary page 1.
- K972313: The Maestro System, BioHorizons Implant Systems, Inc. (1997) Summary page 1.
- K020133: Modification to the Maestro System, BioHorizons Implant Systems, Inc. (2002)
- K020645: Modification to the Maestro System, BioHorizons Implant Systems, Inc. (2002) Summary page 1.
- K992334: Endosseous Implants and Abutments- Tin Coating, Implant Innovations, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K041938: Maximus OS (Overdenture System) (2004), 271 descendants of its own
- K063364: Alpha Bio Dental Implant System (2007), 187 descendants of its own
- K081653: Mdi Mii One-Piece Implant, 2.9MM (2008), 141 descendants of its own

## Indications for use
The Maestro SystemTM may be used in the mandible or maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

Source page: https://510kreport.com/device/K022795
Methodology: https://510kreport.com/methodology