# K083112: Primado

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Apr 29, 2009 after 190 days
- Product code: HBC (Motor, Drill, Electric)
- Device class: 2
- Regulation: 21 CFR 882.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002523 (2000). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080722: Primado Surgical Drill, Nakanishi, Inc. (2008) Summary page 1.
- K002523: Advantage Drive System, Linvatec Corp. (2000) Summary page 1.

## Most influential descendants
- K132264: PRIMADO2 Total Surgical System (2013), 6 descendants of its own
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own
- K213221: AMADEO, M-UK1015 (incl. attachments and accessories) (2022), 1 descendant of its own
- K202120: P300 Attachment (2021), 1 descendant of its own
- K252662: UniBur (2025), 0 descendants of its own

## Indications for use
The Primado is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological, maxillofacial, craniotomy, and spinal procedures, and in the ear nose, and throat area. A wide range of attachments includes a perforator drive, craniotome, straight/angle/maileable drills, and microsaws.

Source page: https://510kreport.com/device/K083112
Methodology: https://510kreport.com/methodology