# K041938: Maximus OS (Overdenture System)

- Pathway: 510(k) (Special)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Jul 22, 2004 after 3 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K960026 (1996). 14 ancestors in all.
271 later devices descend from it; 6 cite it directly.
0 of 286 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032351: The Maestro System 3.0MM Diameter Implant, BioHorizons Implant Systems, Inc. (2003) Summary page 1.
- K023067: Imtec Sendax Mdi ORTHO6 and ORTHO8, Imtec Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own
- K133592: Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua and Drive Smart Acqua, Titamax CM (2014), 109 descendants of its own

## Recalls of this device
- Apr 18, 2007 · Not classified · Z-0801-2007: Dental implant system is missing ball attachment system.
- Dec 28, 2005 · Not classified · Z-0252-2007: Dental implants were distributed which lacked the proper instruments for implantation.

## Indications for use
The BioHorizons Maximus OS Implant may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.

Source page: https://510kreport.com/device/K041938
Methodology: https://510kreport.com/methodology