Atlas FDA

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

FDA 510(k) clearance K212194 · decided 2023-02-16

Clearance details

K-number
K212194
Device name
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
Applicant
Stryker Corporation
Decision
Substantially Equivalent
Date received
2021-07-14
Decision date
2023-02-16
Days to decision
582 days
Clearance type
Traditional
Product code
HAW
Device class
2
Regulation number
882.4560
Medical specialty
Neurology
Advisory committee
Neurology
Location
Freiburg, DE
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Stryker Corporation

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Leksell® Vantage Stereotactic System (K261932)Elekta Solutions AB2026-08-05
Zeta Navigation System (K253663)Zeta Surgical, Inc.2026-05-01
Stealth AXiS Cranial clinical application (K253379)Medtronic Navigation, Inc.2026-03-26
NeuroAlign software (K231897)Medivis, Inc.2025-10-21
SOLOPASS 2.0 System (K251317)Intravent Medical Partners2025-09-05
Ball Joint Guide Array (66295) (K250893)Bayer Medical Care, Inc.2025-09-04
EZ-FIDUCIALS (K250505)Phasor Health, LLC2025-07-09
Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575)Brain Navi Biotechnology Co., Ltd.2025-05-23
Navient Image Guide Navigation System (955-NC-NC), Cranial (K241327)Claronav2025-02-05
Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (K243698)Brainlab AG2025-01-28
ClearPoint System (Software Version 3.0) (K243657)ClearPoint Neuro, Inc.2025-01-24
Geniant Cranial (Navigated Neurosurgical Positioning Robot) (K241333)Koh Young Technology, Inc.2025-01-17

Recalls involving this device

RecordFirmDate
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed ci recall (Z-0963-2026)Howmedica Osteonics Corp.2025-12-19

PMA approvals by this applicant

RecordFirmDate
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005)Stryker Corporation2016-08-09
SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004)Stryker Corporation2007-09-28
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003)Stryker Corporation2002-12-31
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002)Stryker Corporation1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001)Stryker Corporation1998-06-04
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053)Stryker Corporation1997-06-19