# K133050: One Plus Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osseofuse, Inc.
- Decided: Sep 19, 2014 after 357 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: 12 generations back to K960026 (1996). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083067: MS System, Osstem Implant Co., Ltd. (2009) Summary page 4.
- K112540: S-Mini Implant System, Neobiotech Co., Ltd. (2012) Summary page 4.
- K110577: Osseofuse Dental Implant System, Dynamic Innovations, Inc. (2011) Summary page 4.
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 4.
- K023952: Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite, Nobel Biocare Uas, Inc. (2003) Summary page 4.
- K050506: Primasolo One-Piece Implants & Healing Caps, Lifecore Biomedical, Inc. (2005) Summary page 4.

## Most influential descendants
- K151970: KJ Mini Implant System (2016), 0 descendants of its own

## Indications for use
The One Plus Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The One Plus Implant System is intended for single use only. It is for delayed loading.

Source page: https://510kreport.com/device/K133050
Methodology: https://510kreport.com/methodology