# K181157: Conical Plus Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osseofuse International, Inc.
- Decided: May 24, 2019 after 388 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K243078: HexaPLUS S OneDrill Implant System (2025), 0 descendants of its own

## Indications for use
The Conical Plus 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 systems is intended for delayed loading.

Source page: https://510kreport.com/device/K181157
Methodology: https://510kreport.com/methodology