Cleared Traditional

K231494 - CoreLink Robotic Navigation Instruments

K231494 is the FDA 510(k) clearance for CoreLink Robotic Navigation Instruments by Corelink, LLC. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K231494 · Corelink, LLC · Orthopedic device
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Oct 2023
Decision
157d
Days
Class 2
Risk

K231494 is an FDA 510(k) clearance for the CoreLink 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 Corelink, LLC (St. Louis, US). The FDA issued a Cleared decision on October 27, 2023 after a review of 157 days - an extended review 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: 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 Corelink, LLC devices

Submission Details

510(k) Number K231494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2023
Decision Date October 27, 2023
Days to Decision 157 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
35d slower than avg
Panel avg: 122d · This submission: 157d
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 Consultant

Empirical Technologies
Nathan Wright

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K231494.
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
ATEC Posterior Navigated Disc Prep Instruments
K232345 · Alphatec Spine, Inc. · Nov 2023
TMINI™ Miniature Robotic System
K232802 · THINK Surgical, Inc. · Oct 2023
Invictus Robotic Navigation Instruments
K232044 · Alphatec Spine, Inc. · Oct 2023
TriALTIS Navigation Enabled Instruments
K231527 · Medos International S?rl · Sep 2023