Cleared Traditional

K223553 - Spine Planning (2.0)

K223553 is the FDA 510(k) clearance for Spine Planning (2.0) by Brainlab AG. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K223553 · Brainlab AG · Orthopedic device
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Aug 2023
Decision
250d
Days
Class 2
Risk

K223553 is an FDA 510(k) clearance for the Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine. 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 August 2, 2023 after a review of 250 days - an extended review 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: 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 K223553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2022
Decision Date August 02, 2023
Days to Decision 250 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
128d slower than avg
Panel avg: 122d · This submission: 250d
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 K223553.
TriALTIS Navigation Enabled Instruments
K231527 · Medos International S?rl · Sep 2023
Fusion Robotic Navigation System
K232413 · Alphatec Spine, Inc. · Sep 2023
CoreLink Navigation Instruments
K232116 · Corelink, LLC · Aug 2023
REAL INTELLIGENCE™ CORI™
K231963 · Blue Belt Technologies, Inc. · Aug 2023
SURGIVISIO Device
K231886 · Ecential Robotics · Jul 2023
ApolloKnee
K231172 · Corin U.S.A. Limited · Jul 2023