Cleared Traditional

Black Diamond Navigation Instruments (K192495) - FDA 510(k) Clearance

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

K192495 · Osseus Fusion Systems · Orthopedic device
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Jan 2020
Decision
128d
Days
Class 2
Risk

K192495 is an FDA 510(k) clearance for the Black Diamond 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 Osseus Fusion Systems (Dallas, US). The FDA issued a Cleared decision on January 17, 2020 after a review of 128 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 Osseus Fusion Systems devices

Submission Details

510(k) Number K192495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2019
Decision Date January 17, 2020
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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

The OrthoMedix Group, Inc.
J. D. Webb

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 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K192495.
OrthAlign Plus System
K200642 · Orthalign, Inc. · Apr 2020
Real Intelligence Cori
K193120 · Blue Belt Technologies, Inc. · Feb 2020
Mako Total Hip Application
K193128 · Mako Surgical Corp. · Feb 2020
Spinal Elements Navigated Instruments
K190881 · Spinal Elements, Inc. · Dec 2019
Corelink Navigation Instruments
K182731 · Corelink, LLC · Dec 2019
TSolution One Total Knee Application
K193135 · THINK Surgical, Inc. · Dec 2019