510(k) · Cleared
Recalled · Class II · 2013Stryker Consolidated Operating Room Equipment (Core)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Mar 3, 2004 as substantially equivalent to K032303 (Stryker Instruments, 2004) and 7 other predicates after a 23-day review. Its family tree reaches back 6 generations to 1993. 7 later devices descend from it. It has been recalled 8 times.
- Decided
- Mar 3, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- ERL
- 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 deviceK040300 Stryker Consolidated Operating Room Equipment (Core)Stryker 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) | K040300 | Stryker Consolidated Operating Room Equipment (Core) | 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 ERL? 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 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…wered Simple Cranial Drill, Burrs, Trephines and their Accessories (per 21 CFR section 8 82.43 10) Equivalent to: Stryker CORE Console (K032303), Stryker TPS Plus (K0321 17) Stryker TPS (Dental-K943 540, ENT-K943 569, Neuro-… | 2004 |
| * | K032117 | Stryker Total Performance (TPS) SystemSummary page 1…Burrs, Trephines and their Accessories (per 21 CFR section 8 82.43 10) Equivalent to: Stryker CORE Console (K032303), Stryker TPS Plus (K0321 17) Stryker TPS (Dental-K943 540, ENT-K943 569, Neuro- K1943541), TPS Hermes (K99169… | 2003 |
| * | K943540 | Surgical Cutting BursSummary page 1…essories (per 21 CFR section 8 82.43 10) Equivalent to: Stryker CORE Console (K032303), Stryker TPS Plus (K0321 17) Stryker TPS (Dental-K943 540, ENT-K943 569, Neuro- K1943541), TPS Hermes (K991696), Stryker Navigation System… | 1994 |
| * | K943569 | Stryker Total Performance SystemSummary page 1…21 CFR section 8 82.43 10) Equivalent to: Stryker CORE Console (K032303), Stryker TPS Plus (K0321 17) Stryker TPS (Dental-K943 540, ENT-K943 569, Neuro- K1943541), TPS Hermes (K991696), Stryker Navigation System (K"012380) and… | 1995 |
| * | K943541 | 75K Staight DrillSummary page 1…Stryker CORE Console (K032303), Stryker TPS Plus (K0321 17) Stryker TPS (Dental-K943 540, ENT-K943 569, Neuro- K1943541), TPS Hermes (K991696), Stryker Navigation System (K"012380) and Dyonics (K771218). Device Description:… | 1995 |
| * | K991696 | Stryker Hermes-Ready Total Performance SystemSummary page 1…Console (K032303), Stryker TPS Plus (K0321 17) Stryker TPS (Dental-K943 540, ENT-K943 569, Neuro- K1943541), TPS Hermes (K991696), Stryker Navigation System (K"012380) 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-K943 540, ENT-K943 569, Neuro- K1943541), TPS Hermes (K991696), Stryker Navigation System (K"012380) and Dyonics (K771218). Device Description: The device description of the Stryker System includes drills,… | 2001 |
| * | K771218 | Intra-Articular ShaverSummary page 1…(Dental-K943 540, ENT-K943 569, Neuro- K1943541), TPS Hermes (K991696), Stryker Navigation System (K"012380) 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 |
|---|---|---|---|---|
| Jul 1, 2013 | Class II | Z-1741-2013 | Process change control | The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a… |
| Jul 1, 2013 | Class II | Z-1742-2013 | Process change control | The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a… |
| Jul 1, 2013 | Class II | Z-1740-2013 | Process change control | The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a… |
| Jul 6, 2009 | Not classified | Z-0595-2010 | Device Design | The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both. |
| Jul 6, 2009 | Not classified | Z-0597-2010 | Device Design | The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both. |
| Jul 6, 2009 | Not classified | Z-0599-2010 | Device Design | The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both. |
| Jul 6, 2009 | Not classified | Z-0596-2010 | Device Design | The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both. |
| Jul 6, 2009 | Not classified | Z-0598-2010 | Device Design | The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both. |
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 ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 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 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/K040300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040300: Stryker Consolidated Operating Room Equipment (Core).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040300
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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