# K040369: Stryker Consolidated Operating Room Equipment (Core) System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Apr 1, 2004 after 48 days
- Product code: DZJ (Driver, Wire, And Bone Drill, Manual)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931783 (1993). 17 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032303: Stryker Consolidated Operating Room Equipment (Core) System, Stryker Instruments (2004) Summary page 1.
- K032117: Stryker Total Performance (TPS) System, Stryker Instruments (2003) Summary page 1.
- 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
- K132264: PRIMADO2 Total Surgical System (2013), 6 descendants of its own
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own
- K213221: AMADEO, M-UK1015 (incl. attachments and accessories) (2022), 1 descendant of its own
- K202120: P300 Attachment (2021), 1 descendant of its own
- K252662: UniBur (2025), 0 descendants of its own

## Recalls of this device
- Oct 18, 2011 · Not classified · Z-0195-2012: 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 swallo
- Oct 18, 2011 · Not classified · Z-0197-2012: 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 swallo
- Oct 18, 2011 · Not classified · Z-0196-2012: 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 swallo
- Oct 18, 2011 · Not classified · Z-0198-2012: 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 swallo
- Oct 18, 2011 · Not classified · Z-0199-2012: 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 swallo
- Oct 5, 2009 · Not classified · Z-0263-2010: 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: 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: Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.

## 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, 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.

Source page: https://510kreport.com/device/K040369
Methodology: https://510kreport.com/methodology