510(k) Report

510(k) · Cleared

Recalled · 2010

Stryker Consolidated Operating Room Equipment (Core) System

K032303510(k) TraditionalCleared Jan 16, 2004175-day reviewClass II21 CFR 882.4310Recalls 65

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Instruments · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

Cleared on Jan 16, 2004 as substantially equivalent to K943540 (Stryker Corp., 1994) and 5 other predicates after a 175-day review. Its family tree reaches back 5 generations to 1993. 14 later devices descend from it. It has been recalled 65 times.

Decided
Jan 16, 2004
Review
175 days
Class
Class II
Product code
HBE
Recalls
65
Predicates
6

Its longest line of descent runs back 5 generations to K931783 (1993). 15 ancestors in all, the oldest K771218 (1978). 14 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1995: 2 other ancestors1994: 4 other ancestors1978: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor2004: 2 descendants cleared2007: 1 descendant cleared2013: 1 descendant cleared2025: 2 descendants cleared2017: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2024: 4 descendants cleared2023: 1 descendant clearedK931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996×2: 2 generations cleared close together, K973700 (1998), K980787 (1998) K991696 · Stryker Hermes-Ready Total Performance System · Stryker Instruments · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 3 descendants K991696 · Stryker Hermes-Ready Total Performance System · Stryker Instruments · 1999K980787 · Hermes Operating Room Control Center with the Wom 20L Insufflator · Computer Motion, Inc. · 1998K973700 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1998K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996K931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993−50
  1. Root · 5 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 4 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
  3. 3 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
  4. 2 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
  5. 1 generation backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
  6. This deviceK032303 Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments · 2004
  7. Descendant · cites it directly · 7 of its ownK040369 Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments · 2004 · Recalled
  8. Descendant · cites it directly · 7 of its ownK040300 Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments · 2004 · Recalled
  9. Descendant · 2 generations on · 6 of its ownK132264 PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013
  10. Descendant · cites it directly · 4 of its ownK071859 Stryker Crossfire SystemStryker Endoscopy · 2007 · Recalled
  11. Descendant · 2 generations on · 2 of its ownK162770 Relign SystemRelign Corporation · 2017

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2004: 22007: 12013: 12017: 12021: 12022: 12023: 12024: 42025: 2
2004high 4 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 14 · See all
  • K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments · 2004 · cites it directly7descendants
  • K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments · 2004 · cites it directly7descendants
  • K132264PRIMADO2 Total Surgical SystemNakanishi, Inc. · 2013 · 2 generations on6descendants
  • K071859Stryker Crossfire SystemStryker Endoscopy · 2007 · cites it directly4descendants
  • K162770Relign SystemRelign Corporation · 2017 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K931783Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc.1993—
−4K960655Aesop System and AccessoriesComputer Motion, Inc.1996—
−3K973700Hermes Operating Room Control CenterComputer Motion, Inc.1998—
−2K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc.1998—
−1K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999—
0 (this device)K032303Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments2004—
+1K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments20048
+1K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments20048
+2K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.2013—
+1K071859Stryker Crossfire SystemStryker Endoscopy20072
+2K162770Relign SystemRelign Corporation2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199440
199520
199610
199810
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200710
201310
201710
202110
202210
202310
202440
202520
FIG. 1 — Lineage of K032303, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HBE? 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 HBE device

  1. #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K943540Surgical Cutting Burs
Summary page 1
…wered Simple Cranial Drill, Burrs, Trephines and their Accessories (per 21 CFR section 882.4310) Equivalent to! Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541), TPS Hermes (991696), Stryker Navigation System (K012380) and Dyonics…
Stryker Corp.19941
*K943569Stryker Total Performance System
Summary page 1
…Cranial Drill, Burrs, Trephines and their Accessories (per 21 CFR section 882.4310) Equivalent to! Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541), TPS Hermes (991696), Stryker Navigation System (K012380) and Dyonics…
Stryker Corp.1995—
*K94354175K Staight Drill
Summary page 1
…s. Technological Technological characteristics are the same as previously cleared Comparison: for the Stryker TPS System (K943540, K943569, K943541, and K991696), Stryker Navigation System (K012380) and Dyonics (K771218).…
Stryker Corp.1995—
*K991696Stryker Hermes-Ready Total Performance System
Summary page 1
…gical characteristics are the same as previously cleared Comparison: for the Stryker TPS System (K943540, K943569, K943541, and K991696), Stryker Navigation System (K012380) and Dyonics (K771218). Submitted by: Jean W. Shepp…
Stryker Instruments1999—
*K012380Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy
Summary page 1
…882.4310) Equivalent to! Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541), TPS Hermes (991696), Stryker Navigation System (K012380) and Dyonics (K771218). Device Description: The device description of the Stryker System include…
Stryker Leibinger20011
*K771218Intra-Articular Shaver
Summary page 1
…S (Dental-K943540, ENT-K943569, Neuro- 943541), TPS Hermes (991696), Stryker Navigation System (K012380) and Dyonics (K771218). Device Description: The device description of the Stryker System includes drills, shavers, shi…
Dyonics, Inc.1978—

Also cleared against K943540: 4 other devices →

What descends from it? (14)

See all 14

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments20047
K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments20047
K071859Stryker Crossfire SystemStryker Endoscopy20074

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 30, 2010Not classifiedZ-1244-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1240-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1242-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1233-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1238-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1239-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1237-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1241-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1236-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1243-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1235-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1232-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Nov 30, 2010Not classifiedZ-1234-2011PackagingProduct was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
Jul 6, 2009Not classifiedZ-0598-2010Device DesignThe bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
Jul 6, 2009Not classifiedZ-0596-2010Device DesignThe bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
Jul 6, 2009Not classifiedZ-0597-2010Device DesignThe bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
Jul 6, 2009Not classifiedZ-0595-2010Device DesignThe bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
Jul 6, 2009Not classifiedZ-0599-2010Device DesignThe bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
Jan 10, 2008Not classifiedZ-1027-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1024-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1030-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1000-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-0993-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1032-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1007-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1013-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1026-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1020-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1028-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-0992-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-0999-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1025-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1004-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-0989-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1015-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1011-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1034-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1014-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-0994-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1019-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-0991-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1022-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1023-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-0995-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-0997-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1033-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1012-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-0998-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1016-2008Package design/selectionLack of assurance of sterility.
Jan 10, 2008Not classifiedZ-1001-2008Package design/selectionLack of assurance of sterility.

The 5 latest of 50 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.
  • 3 of the 15 ancestors have a recall of any class.
  • Of its descendants, K040369 (Stryker Instruments, 2004) has gone furthest, with 7 descendants of its own.
  • 4 other devices also cite its predicate K943540.

How does its category compare?

All HBE devices

HBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBE

6in 2025

2007: 22008: 22011: 22012: 12013: 12014: 22015: 32016: 22017: 22018: 22019: 52021: 62022: 22023: 22025: 62026 (partial year): 1
2007high 6 (2021) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBE

30in 2025

2015: 155 days median2019: 133 days median2021: 193 days median2025: 30 days median
2007high 193 (2021) · low 30 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HBE

1in 2024

2008: 472009: 72010: 232011: 12012: 262013: 42016: 72017: 32021: 12023: 32024: 12026 (partial year): 19
2007high 47 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HBE

1,924in 2025

2007: 142008: 142009: 2422010: 4922011: 1,0132012: 1,1462013: 1,5832014: 5592015: 4832016: 8482017: 8482018: 7872019: 8362020: 1,0252021: 1,0472022: 9002023: 9482024: 1,1532025: 1,924
2007high 1,924 (2025) · low 14 (2007)2025

MAUDE reports naming product code HBE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—014
20082—4714
20090—7242
20100—23492
20112—11,013
20121—261,146
20131—41,583
20142—0559
201531550483
20162—7848
20172—3848
20182—0787
201951330836
20200—01,025
2021619311,047
20222—0900
20232—3948
20240—11,153
202563001,924
20261—19—

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 and bone cement in a variety of surgical procedures, including but not limited to Neuro and Enndoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The cndoscopic applications with CORE include use with the SE5 Small Joint Shaver in the…

Read the full statement (115 words)

The Stryker Consolidated Operating Room Equipment (CORE)System is 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 Enndoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

The cndoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, ,uticular cartilage flaps. or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

Indications for use as stated in the FDA summary.

Also cleared against K943540

4 other devices cite the same predicate.

  • K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments · 20048 recalls
  • K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments · 20048 recalls
  • K032117Stryker Total Performance (TPS) SystemStryker Instruments · 2003
  • K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999

More from Stryker Instruments

77 FDA decisions under this applicant name. See the company

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  • K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K261544Hydro Irrigation SystemStryker Instruments · 2026
  • K253679Hydro Irrigation SystemStryker Instruments · 2026

Recent decisions in HBE

The HBE category page

  • K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo…Surgify Medical OY · 202611 recalls
  • K250815Hubly Drill (H100)Hubly, Inc. · 2025
  • K252060GREENPhasor Health, LLC · 2025
  • K252662UniBurNakanishi, Inc. · 2025
  • K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20253 recalls

https://510kreport.com/device/K032303 · printed Nov 3, 2026

Cite this page

510(k) Report. “K032303: Stryker Consolidated Operating Room Equipment (Core) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032303

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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