# K151599: iSy Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Altatec GmbH
- Decided: Oct 2, 2015 after 112 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: 13 generations back to K894595 (1990). 195 ancestors in all.
No later device cites it as a predicate yet.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133991: ISY, Altatec GmbH (2014) Summary page 5.

## Indications for use
iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

Source page: https://510kreport.com/device/K151599
Methodology: https://510kreport.com/methodology