Cleared Special

K260546 - Q Pedicle Instruments

K260546 is the FDA 510(k) clearance for Q Pedicle Instruments by K2m, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Special 510(k) pathway after a 27-day FDA review.

K260546 · K2m, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
27d
Days
Class 2
Risk

K260546 is an FDA 510(k) clearance for the Q Pedicle Instruments. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on March 17, 2026 after a review of 27 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 K2m, Inc. devices

Submission Details

510(k) Number K260546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2026
Decision Date March 17, 2026
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K260546.
CUVIS-joint (CJ150)
K252037 · Curexo, Inc. · Mar 2026
TiLink-L Navigation Instruments
K253604 · SurGenTec, LLC · Mar 2026
EUROPA™ Posterior Cervical Fusion Navigated Instruments
K253444 · MiRus, LLC · Mar 2026
TMINI® Miniature Robotic System
K260010 · THINK Surgical, Inc. · Mar 2026
Mako Total Knee Application
K260222 · Mako Surgical Corp. · Feb 2026
“POINT” Kinguide Agile Hybrid Navigation System
K252989 · Point Robotics MedTech, Inc. · Feb 2026