# K101913: Anthofit OI, Anthofit HE, Ossfit and Axiom

- Pathway: 510(k) (Abbreviated)
- Applicant: Anthogyr Sas
- Decided: Mar 11, 2011 after 246 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K960026 (1996). 35 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics, Lifecore Biomedical, Inc. (2005) Summary page 1.

## Most influential descendants
- K131066: Axiom Reg (2014), 2 descendants of its own
- K161177: Axiom PX (2017), 0 descendants of its own
- K141450: AXIOM 2.8 (2014), 0 descendants of its own

## Recalls of this device
- Jun 20, 2016 · Class II · Z-2753-2016: Following a FDA inspection showing that the firm failed to validate the design and process of its implants.

## Indications for use
ANTHOGYR Dental Implant System AXIOM is intended for use in partially or fully edlentulous 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.

Source page: https://510kreport.com/device/K101913
Methodology: https://510kreport.com/methodology