Cleared Traditional

K252742 - Navigated Instruments

K252742 is the FDA 510(k) clearance for Navigated Instruments by Tyber Medical, LLC. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K252742 · Tyber Medical, LLC · Orthopedic device
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Oct 2025
Decision
61d
Days
Class 2
Risk

K252742 is an FDA 510(k) clearance for the Navigated 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 Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on October 28, 2025 after a review of 61 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 K252742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2025
Decision Date October 28, 2025
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
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 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K252742.
Rosa® Knee System
K251314 · Orthosoft Inc. (d/b/a) Zimmer CAS · Nov 2025
ExcelsiusGPS™ Instruments
K250599 · Globus Medical, Inc. · Nov 2025
Firebird SI Navigation System
K252088 · Orthofix US, LLC · Oct 2025
OsteoCentric Navigated Instruments System
K250520 · Osteocentric Technologies, Inc. · Oct 2025
StealthStation S8 Spine Software
K251282 · Medtronic Navigation, Inc. · Oct 2025
TMINI Miniature Robotic System
K252544 · THINK Surgical, Inc. · Oct 2025