# K040300: Stryker Consolidated Operating Room Equipment (Core)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Mar 3, 2004 after 23 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- 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
- Jul 1, 2013 · Class II · Z-1741-2013: 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 u
- Jul 1, 2013 · Class II · Z-1742-2013: 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 u
- Jul 1, 2013 · Class II · Z-1740-2013: 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 u
- 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-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-0599-2010: 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-0598-2010: The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.

## 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 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/K040300
Methodology: https://510kreport.com/methodology