# K161399: Neocis Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Neocis, Inc.
- Decided: Dec 22, 2016 after 216 days
- Product code: PLV (Dental Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 872.4120
- 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: 3 generations back to K983831 (1999). 4 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150222: X-Guide Surgical Navigation System, X-Nav Technologies, LLC (2015) Summary page 4.

## Most influential descendants
- K202264: Neocis Guidance System (NGS) with Yomi Plan v2.0 (2020), 7 descendants of its own
- K210711: Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (2021), 5 descendants of its own
- K173402: Neocis Guidance System (NGS) with Chairside Splint (2018), 5 descendants of its own
- K222049: Yomi Robotic System (2022), 4 descendants of its own
- K222750: Yomi Robotic System (2022), 3 descendants of its own

## Recalls of this device
- Oct 4, 2019 · Class II · Z-0511-2020: The Fiducial Array may mismatch their measurement files resulting in failed landmark check.

## Indications for use
The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

Source page: https://510kreport.com/device/K161399
Methodology: https://510kreport.com/methodology