# K202120: P300 Attachment

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Oct 22, 2021 after 449 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931783 (1993). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132264: PRIMADO2 Total Surgical System, Nakanishi, Inc. (2013) Summary page 5.

## Most influential descendants
- K252662: UniBur (2025), 0 descendants of its own

## Indications for use
The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery. NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.

Source page: https://510kreport.com/device/K202120
Methodology: https://510kreport.com/methodology