Cleared Special

K222966 - Cirq Arm System (2.0)

Also marketed or referenced as:
Alignment System Spine

K222966 is the FDA 510(k) clearance for Cirq Arm System (2.0) by Brainlab AG. It is a Class 2 Orthopedic device (product code OLO) cleared through the Special 510(k) pathway after a 30-day FDA review.

K222966 · Brainlab AG · Orthopedic device
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Oct 2022
Decision
30d
Days
Class 2
Risk

K222966 is an FDA 510(k) clearance for the Cirq Arm System (2.0). Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on October 27, 2022 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Brainlab AG devices

Submission Details

510(k) Number K222966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2022
Decision Date October 27, 2022
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K222966.
RobPath® Total Hip Application
K220774 · Hangzhou Lancet Robotics Co., Ltd. · Dec 2022
SeaSpine 7D Navigation Instruments
K222753 · SeaSpine Orthopedics Corporation · Dec 2022
Remi Robotic Navigation System
K223070 · Fusion Robotics, LLC · Oct 2022
CUVIS-spine
K222698 · Curexo, Inc. · Oct 2022
ROSA® Knee System
K221928 · Orthosoft D/B/A Zimmer Cas · Oct 2022
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition
K222383 · Medtronic Sofamor Danek USA, Inc. · Sep 2022