Cleared Traditional

ROSA ONE Spine application (K192173) - FDA 510(k) Clearance

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

K192173 · Medtech S.A · Orthopedic device
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Oct 2019
Decision
78d
Days
Class 2
Risk

K192173 is an FDA 510(k) clearance for the ROSA ONE Spine application. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Medtech S.A (Montpellier, FR). The FDA issued a Cleared decision on October 29, 2019 after a review of 78 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 Medtech S.A devices

Submission Details

510(k) Number K192173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2019
Decision Date October 29, 2019
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
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 428
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K192173.
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
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K254157 · Medos International SARL · May 2026
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ROSA® Shoulder System
K260582 · Orthosoft Inc. (d/b/a) Zimmer CAS · May 2026
Pytheas Your Guided Trajectory
K252880 · Pytheas Navigation Sas · May 2026