510(k) · Cleared
Recalled · 2011Stryker Consolidated Operating Room Equipment (Core) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · DZJ Driver, Wire, And Bone Drill, Manual
Cleared on Apr 1, 2004 as substantially equivalent to K032303 (Stryker Instruments, 2004) and 7 other predicates after a 48-day review. Its family tree reaches back 6 generations to 1993. 7 later devices descend from it. It has been recalled 8 times.
- Decided
- Apr 1, 2004
- Review
- 48 days
- Class
- Class II
- Product code
- DZJ
- Recalls
- 8
- Predicates
- 8
Its longest line of descent runs back 6 generations to K931783 (1993). 17 ancestors in all, the oldest K771218 (1978). 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 4 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 3 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 2 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 1 generation backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- This deviceK040369 Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments · 2004
- 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 |
|---|---|---|---|---|---|
| −6 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −5 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −4 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −3 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −2 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −1 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| 0 (this device) | K040369 | Stryker Consolidated Operating Room Equipment (Core) System | Stryker Instruments | 2004 | — |
| +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 |
|---|---|---|
| 1978 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 DZJ? 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 DZJ device
- #1 K243637 Materialise Personalized Guides and Models for…score 13.7 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K032303 | Stryker Consolidated Operating Room Equipment (Core) SystemSummary page 1…Powered Simple Cranial Drill, Burrs, Trephines and their Accessories (per 21 CFR section 882.4310) Equivalent to: Stryker CORE Console (K032303), Stryker TPS Plus (K032117) Stryker TPS (Dental-K943540, ENT-K943569, Neuro-… | 2004 |
| * | K032117 | Stryker Total Performance (TPS) SystemSummary page 1…, Burrs, Trephines and their Accessories (per 21 CFR section 882.4310) Equivalent to: Stryker CORE Console (K032303), Stryker TPS Plus (K032117) Stryker TPS (Dental-K943540, ENT-K943569, Neuro- K943541), TPS Hermes (K99… | 2003 |
| * | K943540 | Surgical Cutting BursSummary page 1…Accessories (per 21 CFR section 882.4310) Equivalent to: Stryker CORE Console (K032303), Stryker TPS Plus (K032117) Stryker TPS (Dental-K943540, ENT-K943569, Neuro- K943541), TPS Hermes (K991696), Stryker Navigation System… | 1994 |
| * | K943569 | Stryker Total Performance SystemSummary page 1…CFR section 882.4310) Equivalent to: Stryker CORE Console (K032303), Stryker TPS Plus (K032117) Stryker TPS (Dental-K943540, ENT-K943569, Neuro- K943541), TPS Hermes (K991696), Stryker Navigation System (K012380) and… | 1995 |
| * | K943541 | 75K Staight DrillSummary page 1…Stryker CORE Console (K032303), Stryker TPS Plus (K032117) Stryker TPS (Dental-K943540, ENT-K943569, Neuro- K943541), TPS Hermes (K991696), Stryker Navigation System (K012380) and Dyonics (K771218). Device Description:… | 1995 |
| * | K991696 | Stryker Hermes-Ready Total Performance SystemSummary page 1…onsole (K032303), Stryker TPS Plus (K032117) Stryker TPS (Dental-K943540, ENT-K943569, Neuro- K943541), TPS Hermes (K991696), Stryker Navigation System (K012380) and Dyonics (K771218). Device Description: The device descrip… | 1999 |
| * | K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual FluoroscopySummary page 1…Stryker TPS (Dental-K943540, ENT-K943569, Neuro- K943541), TPS Hermes (K991696), Stryker Navigation System (K012380) and Dyonics (K771218). Device Description: The device description of the Stryker System includes drills,… | 2001 |
| * | K771218 | Intra-Articular ShaverSummary page 1…ntal-K943540, ENT-K943569, Neuro- K943541), TPS Hermes (K991696), Stryker Navigation System (K012380) and Dyonics (K771218). Device Description: The device description of the Stryker System includes drills, shavers, shields… | 1978 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 18, 2011 | Not classified | Z-0195-2012 | Device Design | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a… |
| Oct 18, 2011 | Not classified | Z-0197-2012 | Device Design | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a… |
| Oct 18, 2011 | Not classified | Z-0196-2012 | Device Design | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a… |
| Oct 18, 2011 | Not classified | Z-0198-2012 | Device Design | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a… |
| Oct 18, 2011 | Not classified | Z-0199-2012 | Device Design | There is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being aspirated or swallowed, additional surgery to remove a… |
| Oct 5, 2009 | Not classified | Z-0263-2010 | Vendor change control | The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device. |
| Aug 5, 2005 | Not classified | Z-1389-05 | Other | Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current. |
| Aug 5, 2005 | Not classified | Z-1390-05 | Other | Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K132264 (Nakanishi, Inc., 2013) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K032303.
How does its category compare?
All DZJ devicesDZJ Driver, Wire, And Bone Drill, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZJ
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZJ
14in 2025
MAUDE reports naming product code DZJ, 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 | 0 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 142 |
| 2010 | 0 | — | 0 | 517 |
| 2011 | 0 | — | 5 | 578 |
| 2012 | 1 | — | 0 | 621 |
| 2013 | 0 | — | 1 | 809 |
| 2014 | 1 | — | 0 | 539 |
| 2015 | 2 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 2 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 4 | 379 | 0 | 17 |
| 2021 | 3 | 403 | 0 | 22 |
| 2022 | 3 | 179 | 0 | 23 |
| 2023 | 3 | 142 | 0 | 22 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to Dental. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The Stryker Consolidated Operating Room Equipment (CORE) System (K032303) is also, intended for use…
Read the full statement (176 words)
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to Dental. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The Stryker Consolidated Operating Room Equipment (CORE) System (K032303) is also, intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The Stryker Consolidated Operating Room Equipment (CORE) System (K040300) is also, intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in a variety of surgical procedures, including but not limited to ENT. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040369: Stryker Consolidated Operating Room Equipment (Core) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040369
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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