Cleared Traditional

K202320 - CIRQ Robotic Alignment Module

K202320 is the FDA 510(k) clearance for CIRQ Robotic Alignment Module by Brainlab AG. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K202320 · Brainlab AG · Orthopedic device
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Dec 2020
Decision
128d
Days
Class 2
Risk

K202320 is an FDA 510(k) clearance for the CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Ci.... 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 December 23, 2020 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Brainlab AG devices

Submission Details

510(k) Number K202320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2020
Decision Date December 23, 2020
Days to Decision 128 days
Submission Type Traditional
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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K202320.
RESPONSE Navigation Instruments
K203573 · OrthoPediatrics Corp. · Feb 2021
VELYS™ Robotic-Assisted Solution
K202769 · Depuy Ireland UC · Jan 2021
ChoiceSpine Navigation System
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ADAPT for Gamma3
K202749 · Stryker GmbH · Dec 2020
Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration
K200376 · Navbit Pty, Ltd. · Dec 2020
CD Horizon Spinal System Instruments
K203291 · Medtronic Sofamor Danek USA, Inc. · Dec 2020