# K161177: Axiom PX

- Pathway: 510(k) (Abbreviated)
- Applicant: Anthogyr Sas
- Decided: Jun 15, 2017 after 415 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). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131066: Axiom Reg, Anthogyr Sas (2014) Summary page 5.
- K101913: Anthofit OI, Anthofit HE, Ossfit and Axiom, Anthogyr Sas (2011) Summary page 5.
- K992538: Amorphous Diamond Coated Screw, Nobel Biocare Uas, Inc. (1999) Summary page 5.

## Indications for use
Anthogyr dental implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. Anthogyr dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.

Source page: https://510kreport.com/device/K161177
Methodology: https://510kreport.com/methodology