Cleared Traditional

K182731 - Corelink Navigation Instruments

K182731 is the FDA 510(k) clearance for Corelink Navigation Instruments by Corelink, LLC. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K182731 · Corelink, LLC · Orthopedic device
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Dec 2019
Decision
441d
Days
Class 2
Risk

K182731 is an FDA 510(k) clearance for the Corelink 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 December 13, 2019 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Corelink, LLC devices

Submission Details

510(k) Number K182731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date December 13, 2019
Days to Decision 441 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
319d slower than avg
Panel avg: 122d · This submission: 441d
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 K182731.
Mako Total Hip Application
K193128 · Mako Surgical Corp. · Feb 2020
Black Diamond Navigation Instruments
K192495 · Osseus Fusion Systems · Jan 2020
Spinal Elements Navigated Instruments
K190881 · Spinal Elements, Inc. · Dec 2019
TSolution One Total Knee Application
K193135 · THINK Surgical, Inc. · Dec 2019
Vital Navigation System
K191722 · Zimmer Biomet Spine, Inc. · Dec 2019
Navigated Anterolateral Disc Prep Instruments
K192336 · Medtronic Sofamor Danek USA, Inc. · Nov 2019