510(k) · Cleared
ClearedPRIMADO2 Total Surgical System
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 Dec 17, 2013 as substantially equivalent to K083112 (Nakanishi, Inc., 2009) and 4 other predicates after a 148-day review. Its family tree reaches back 7 generations to 1993. 6 later devices descend from it.
- Decided
- Dec 17, 2013
- Review
- 148 days
- Class
- Class II
- Product code
- HBC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K931783 (1993). 47 ancestors in all, the oldest K771218 (1978). 6 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 6 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 5 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 4 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 3 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 2 generations backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- 1 generation backK040300 Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments · 2004 · Recalled
- This deviceK132264 PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK233638 VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK213221 AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022
- Descendant · cites it directly · 1 of its ownK202120 P300 AttachmentNakanishi, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK252662 UniBurNakanishi, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240340 Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K233638VERZA™ High Speed DrillsGlobus Medical, Inc. · 2024 · cites it directly1descendant
- K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH · 2022 · cites it directly1descendant
- K202120P300 AttachmentNakanishi, Inc. · 2021 · cites it directly1descendant
- K252662UniBurNakanishi, Inc. · 2025 · 2 generations on0descendants
- K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −6 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −5 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −4 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −3 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −2 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| −1 | K040300 | Stryker Consolidated Operating Room Equipment (Core) | Stryker Instruments | 2004 | 8 |
| 0 (this device) | K132264 | PRIMADO2 Total Surgical System | Nakanishi, Inc. | 2013 | — |
| +1 | K233638 | VERZA™ High Speed Drills | Globus Medical, Inc. | 2024 | — |
| +1 | K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | 2022 | — |
| +1 | K202120 | P300 Attachment | Nakanishi, Inc. | 2021 | — |
| +2 | K252662 | UniBur | Nakanishi, Inc. | 2025 | — |
| +2 | K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K083112 | PrimadoSummary page 1…EQJ 874.4140 Class 1* Bur, Ear, nose and throat * 5 10(k) Exempt Predicate Device: K0831 12 -Nakanishi Primado Surgical Drill K040369 - Stryker CORE… | 2009 |
| * | K040369 | Stryker Consolidated Operating Room Equipment (Core) SystemSummary page 1…* 5 10(k) Exempt Predicate Device: K0831 12 -Nakanishi Primado Surgical Drill K040369 - Stryker CORE K040300 - Stryker CORE K081475… | 2004 |
| * | K040300 | Stryker Consolidated Operating Room Equipment (Core)Summary page 1…Device: K0831 12 -Nakanishi Primado Surgical Drill K040369 - Stryker CORE K040300 - Stryker CORE K081475 - Medtronic IPC K05352… | 2004 |
| * | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Summary page 1…K040369 - Stryker CORE K040300 - Stryker CORE K081475 - Medtronic IPC K053526 - Aesculap microspeedTM uni Device Description:… | 2008 |
| * | K053526 | Microspeed Uni Motor SystemSummary page 1…K040300 - Stryker CORE K081475 - Medtronic IPC K053526 - Aesculap microspeedTM uni Device Description: The Primado2 consists of the Control Unit, the Motor, the… | 2006 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 10 of the 47 ancestors have a recall of any class.
- Of its descendants, K233638 (Globus Medical, Inc., 2024) has gone furthest, with 1 descendant 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. 2013, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132264 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132264: PRIMADO2 Total Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132264
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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