Cleared Traditional

K243659 - FLASH Facet Fusion Instruments

K243659 is the FDA 510(k) clearance for FLASH Facet Fusion Instruments by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K243659 · SeaSpine Orthopedics Corporation · Orthopedic device
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Apr 2025
Decision
126d
Days
Class 2
Risk

K243659 is an FDA 510(k) clearance for the FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion 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 SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on April 2, 2025 after a review of 126 days - within the typical 510(k) review window.

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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K243659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2024
Decision Date April 02, 2025
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 K243659.
Dynamis Robotic Surgical System
K243326 · LEM Surgical AG · Apr 2025
Medyssey Navigation System
K242806 · Medyssey Co, Ltd. · Apr 2025
Salvo® Robotic Navigation Instruments
K243514 · Spine Wave, Inc. · Apr 2025
Innovasis Navigation Instruments
K250182 · Innovasis, Inc. · Mar 2025
Consolidated Operating Room Equipment (CORE) 2 Console
K243958 · Stryker Instruments · Mar 2025
mBôs (Monogram mBôs TKA System)
K242121 · Monogram Orthopaedics, Inc. · Mar 2025