Cleared Special

Drill Guide (K240701) - FDA 510(k) Clearance

Also marketed or referenced as:
Drill Bit Spine & Trauma Navigation

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240701 · Brainlab AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
70d
Days
Class 2
Risk

K240701 is an FDA 510(k) clearance for the Drill Guide. 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 May 23, 2024 after a review of 70 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 K240701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2024
Decision Date May 23, 2024
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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 428
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K240701.
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
K260571 · Life Spine, Inc. · Jun 2026
Navigated LLIF Impactable Tracker
K261060 · Tyber Medical, LLC · May 2026
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
K254157 · Medos International SARL · May 2026
Ion-C Navigation Instruments
K260329 · SurGenTec, LLC · May 2026
ROSA® Shoulder System
K260582 · Orthosoft Inc. (d/b/a) Zimmer CAS · May 2026
Pytheas Your Guided Trajectory
K252880 · Pytheas Navigation Sas · May 2026