Cleared Traditional

K261060 - Navigated LLIF Impactable Tracker (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K261060 · Tyber Medical, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2026
Decision
59d
Days
Class 2
Risk

K261060 is an FDA 510(k) clearance for the Navigated LLIF Impactable Tracker. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on May 29, 2026 after a review of 59 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 Tyber Medical, LLC devices

Submission Details

510(k) Number K261060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2026
Decision Date May 29, 2026
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 427
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K261060.
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
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · Foundation Surgical Group, Inc. · Apr 2026
SPINEART Navigation Instrument System
K254158 · Spineart SA · Apr 2026
SYMPHONY Navigation Ready Instruments
K260240 · Medos International SARL · Mar 2026