510(k) · Cleared
ClearedPrimado
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakanishi, Inc. · HBC Motor, Drill, Electric
Cleared on Apr 29, 2009 as substantially equivalent to K080722 (Nakanishi, Inc., 2008) and 1 other predicate after a 190-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.
- Decided
- Apr 29, 2009
- Review
- 190 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002523 (2000). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002523 Advantage Drive SystemLinvatec Corp. · 2000
- This deviceK083112 PrimadoNakanishi, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK132264 PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK213221 AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022
- Descendant · 2 generations on · 1 of its ownK202120 P300 AttachmentNakanishi, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK252662 UniBurNakanishi, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K132264PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013 · cites it directly6descendants
- K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · 2 generations on1descendant
- K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022 · 2 generations on1descendant
- K202120P300 AttachmentNakanishi, Inc. · 2021 · 2 generations on1descendant
- K252662UniBurNakanishi, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002523 | Advantage Drive System | Linvatec Corp. | 2000 | — |
| 0 (this device) | K083112 | Primado | Nakanishi, Inc. | 2009 | — |
| +1 | K132264 | PRIMADO2 Total Surgical System | Nakanishi, Inc. | 2013 | — |
| +2 | K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024 | — |
| +2 | K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | 2022 | — |
| +2 | K202120 | P300 Attachment | Nakanishi, Inc. | 2021 | — |
| +3 | K252662 | UniBur | Nakanishi, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HBC device
- #1 K254174 Surgical Power Systemscore 14.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080722 | Primado Surgical DrillSummary page 1…to the first use and after each use. The Primado has already been cleared for marketing for "delicate bone dissection in the ear, nose, and throat areas" under K#080722. The Primado Surgical System is substantially equivalent in terms of safety and effectiveness to NSK's own previ… | 2008 |
| * | K002523 | Advantage Drive SystemSummary page 1…m is substantially equivalent in terms of safety and effectiveness to NSK's own previously authorized Primado device (K#080722) and the Advantage Drive System (K#002523). A chart comparing the Primado to the predicate devices is attached. 5-1… | 2000 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132264 | PRIMADO2 Total Surgical System | 2013 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K132264 (Nakanishi, Inc., 2013) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HBC devicesHBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HBC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HBC
Too few HBC 510(k)s in any year since 2007 to give a median.
Recalls per year · HBC
9in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBC
635in 2025
MAUDE reports naming product code HBC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 9 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 10,670 |
| 2014 | 1 | — | 1 | 2,643 |
| 2015 | 0 | — | 0 | 1,953 |
| 2016 | 1 | — | 0 | 2,541 |
| 2017 | 2 | — | 0 | 2,079 |
| 2018 | 1 | — | 0 | 1,779 |
| 2019 | 1 | — | 0 | 1,703 |
| 2020 | 0 | — | 0 | 1,304 |
| 2021 | 1 | — | 0 | 946 |
| 2022 | 2 | — | 9 | 760 |
| 2023 | 0 | — | 0 | 663 |
| 2024 | 2 | — | 0 | 427 |
| 2025 | 0 | — | 0 | 635 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083112: Primado.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083112
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026