Cleared Traditional

Dark Star Navigation Instrument System (K212028) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212028 · Republic Spine, LLC · Orthopedic device
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Sep 2021
Decision
90d
Days
Class 2
Risk

K212028 is an FDA 510(k) clearance for the Dark Star Navigation Instrument System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Republic Spine, LLC (Boca Raton, US). The FDA issued a Cleared decision on September 27, 2021 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 Republic Spine, LLC devices

Submission Details

510(k) Number K212028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2021
Decision Date September 27, 2021
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 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K212028.
Integrity Implants Navigated Instruments
K212088 · Integrity Implants, Inc. · Dec 2021
REAL INTELLIGENCE CORI (CORI)
K212537 · Blue Belt Technologies, Inc. · Nov 2021
CoreLink Navigation Instruments
K212825 · Corelink, LLC · Oct 2021
Virage Navigation System
K212023 · Zimmer Biomet Spine, Inc. · Aug 2021
ExcelsiusHub
K211616 · Globus Medical, Inc. · Aug 2021
GX Navigation Instrument System
K202836 · Life Spine, Inc. · Aug 2021