Cleared Traditional

K232044 - Invictus Robotic Navigation Instruments

K232044 is the FDA 510(k) clearance for Invictus Robotic Navigation Instruments by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K232044 · Alphatec Spine, Inc. · Orthopedic device
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Oct 2023
Decision
88d
Days
Class 2
Risk

K232044 is an FDA 510(k) clearance for the Invictus Robotic Navigation 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 October 6, 2023 after a review of 88 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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K232044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2023
Decision Date October 06, 2023
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K232044.
ATEC Posterior Navigated Disc Prep Instruments
K232345 · Alphatec Spine, Inc. · Nov 2023
CoreLink Robotic Navigation Instruments
K231494 · Corelink, LLC · Oct 2023
TMINI™ Miniature Robotic System
K232802 · THINK Surgical, Inc. · Oct 2023
TriALTIS Navigation Enabled Instruments
K231527 · Medos International S?rl · Sep 2023
Fusion Robotic Navigation System
K232413 · Alphatec Spine, Inc. · Sep 2023
CoreLink Navigation Instruments
K232116 · Corelink, LLC · Aug 2023