Cleared Traditional

K232345 - ATEC Posterior Navigated Disc Prep Inst...

K232345 is the FDA 510(k) clearance for ATEC Posterior Navigated Disc Prep Inst... by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K232345 · Alphatec Spine, Inc. · Orthopedic device
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Nov 2023
Decision
90d
Days
Class 2
Risk

K232345 is an FDA 510(k) clearance for the ATEC Posterior Navigated Disc Prep 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 Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 2, 2023 after a review of 90 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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K232345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2023
Decision Date November 02, 2023
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K232345.
ExactechGPS® Total Ankle Application
K232521 · Blue Ortho · Nov 2023
ROSA Partial Knee System
K232533 · Orthosoft D/B/A Zimmer Cas · Nov 2023
Vital™ Navigation System
K233443 · Zimvie Spine (Zimmer Biomet Spine, Inc.) · Nov 2023
CoreLink Robotic Navigation Instruments
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TMINI™ Miniature Robotic System
K232802 · THINK Surgical, Inc. · Oct 2023
Invictus Robotic Navigation Instruments
K232044 · Alphatec Spine, Inc. · Oct 2023