Cleared Traditional

K220652 - Knee 3

K220652 is the FDA 510(k) clearance for Knee 3 by Brainlab AG. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K220652 · Brainlab AG · Orthopedic device
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Jun 2022
Decision
88d
Days
Class 2
Risk

K220652 is an FDA 510(k) clearance for the Knee 3. 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 June 3, 2022 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Brainlab AG devices

Submission Details

510(k) Number K220652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2022
Decision Date June 03, 2022
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K220652.
SkyWalker Total Knee System
K213873 · Microport Navibot International, LLC · Jul 2022
ChoiceSpine Navigation System
K220024 · Choice Spine, LLC · Jul 2022
SURGIVISIO Device
K221028 · Ecential Robotics · Jul 2022
CoreLink Navigation Instruments
K220973 · Corelink, LLC · Jun 2022
VisAR
K220146 · Novarad Corporation · May 2022
Spine Guidance Software, Stryker Q Guidance System
K220593 · Stryker Leibinger GmbH & Co KG · May 2022