# K243078: HexaPLUS S OneDrill Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osseofuse International, Inc.
- Decided: Oct 10, 2025 after 375 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: 1 generation back to K181157 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181157: Conical Plus Implant System, Osseofuse International, Inc. (2019) Summary page 5.

## Indications for use
The HexaPLUS S OneDrill Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement-retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. The system is intended for delayed loading.

Source page: https://510kreport.com/device/K243078
Methodology: https://510kreport.com/methodology