# K032303: Stryker Consolidated Operating Room Equipment (Core) System - Pathway: 510(k) (Traditional) - Applicant: Stryker Instruments - Decided: Jan 16, 2004 after 175 days - Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)) - Device class: 2 - Regulation: 21 CFR 882.4310 - Recalls of this device: 65 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K931783 (1993). 15 ancestors in all. 14 later devices descend from it; 3 cite it directly. 0 of 30 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K943540: Surgical Cutting Burs, Stryker Corp. (1994) Summary page 1. - K943569: Stryker Total Performance System, Stryker Corp. (1995) Summary page 1. - K943541: 75K Staight Drill, Stryker Corp. (1995) Summary page 1. - K991696: Stryker Hermes-Ready Total Performance System, Stryker Instruments (1999) Summary page 1. - K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy, Stryker Leibinger (2001) Summary page 1. - K771218: Intra-Articular Shaver, Dyonics, Inc. (1978) Summary page 1. ## Most influential descendants - K040369: Stryker Consolidated Operating Room Equipment (Core) System (2004), 7 descendants of its own - K040300: Stryker Consolidated Operating Room Equipment (Core) (2004), 7 descendants of its own - K132264: PRIMADO2 Total Surgical System (2013), 6 descendants of its own - K071859: Stryker Crossfire System (2007), 4 descendants of its own - K162770: Relign System (2017), 2 descendants of its own ## Recalls of this device - Nov 30, 2010 · Not classified · Z-1244-2011: Product 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, 2010 · Not classified · Z-1240-2011: Product 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, 2010 · Not classified · Z-1242-2011: Product 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, 2010 · Not classified · Z-1233-2011: Product 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, 2010 · Not classified · Z-1238-2011: Product 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, 2010 · Not classified · Z-1239-2011: Product 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, 2010 · Not classified · Z-1237-2011: Product 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, 2010 · Not classified · Z-1241-2011: Product 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, 2010 · Not classified · Z-1236-2011: Product 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, 2010 · Not classified · Z-1243-2011: Product 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, 2010 · Not classified · Z-1235-2011: Product 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, 2010 · Not classified · Z-1232-2011: Product 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, 2010 · Not classified · Z-1234-2011: Product 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, 2009 · Not classified · Z-0598-2010: 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: 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: 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-0595-2010: 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: The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both. - Jan 10, 2008 · Not classified · Z-1027-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1024-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1030-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1000-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-0993-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1032-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1007-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1013-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1026-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1020-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1028-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-0992-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-0999-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1025-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1004-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-0989-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1015-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1011-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1034-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1014-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-0994-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1019-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-0991-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1022-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1023-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-0995-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-0997-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1033-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1012-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-0998-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1016-2008: Lack of assurance of sterility. - Jan 10, 2008 · Not classified · Z-1001-2008: Lack of assurance of sterility. ## Indications for use 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. Source page: https://510kreport.com/device/K032303 Methodology: https://510kreport.com/methodology