# K112593: Styker Consolidated Operating Room Equipment (Core) System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: May 1, 2012 after 237 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker Consolidated Operating Room Equipment (CORE) System: named in the summary without a submission number
- (no number) Synthes Electric Pen Drive (EPD) System: named in the summary without a submission number
- (no number) Stryker Total Performance System: named in the summary without a submission number

## Most influential descendants
- K171840: Stryker Consolidated Operating Room Equipment (CORE) 2 Console (2017), 8 descendants of its own
- K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (2024), 7 descendants of its own
- K141935: Stryker S2 Drill (2014), 7 descendants of its own
- K152641: Pi Drive Plus Motor, Extender (2015), 6 descendants of its own
- K143320: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (2015), 6 descendants of its own

## Indications for use
The Stryker® Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to, dental, ENT (ear, nose, throat), neuro, spine, and endoscopic applications. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

Source page: https://510kreport.com/device/K112593
Methodology: https://510kreport.com/methodology