# K132264: PRIMADO2 Total Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Dec 17, 2013 after 148 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: 7 generations back to K931783 (1993). 47 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083112: Primado, Nakanishi, Inc. (2009) Summary page 1.
- K040369: Stryker Consolidated Operating Room Equipment (Core) System, Stryker Instruments (2004) Summary page 1.
- K040300: Stryker Consolidated Operating Room Equipment (Core), Stryker Instruments (2004) Summary page 1.
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)], Medtronic Xomed, Inc. (2008) Summary page 1.
- K053526: Microspeed Uni Motor System, Aesculap, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K240340: Surgical Drive System (Model: ES70, ES90, E8) (2024), 0 descendants of its own

## Indications for use
The Primado 2 is an AC-electrically powered total surgical system that is intended for cutting drilling, sawing, and otherwise manipulating soft tissue, hard tissue, bone, bone cement. prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including but not limited to Cranial (CraniofaciallMaxillofacial), ENT, Endoscopic /Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical procedures.

Source page: https://510kreport.com/device/K132264
Methodology: https://510kreport.com/methodology