Cleared Traditional

K182848 - ROSA ONE Spine application

K182848 is the FDA 510(k) clearance for ROSA ONE Spine application by Medtech S.A. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K182848 · Medtech S.A · Orthopedic device
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Mar 2019
Decision
164d
Days
Class 2
Risk

K182848 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 March 22, 2019 after a review of 164 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 Medtech S.A devices

Submission Details

510(k) Number K182848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2018
Decision Date March 22, 2019
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
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 K182848.
Stealth-Midas MR8 System
K183644 · Medtronic Powered Surgical Solutions · May 2019
Navigation Enabled Instruments
K183381 · Stryker · May 2019
ExcelsiusGPS
K190653 · Globus Medical, Inc. · Apr 2019
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
K183196 · Stryker Corporation · Feb 2019
ROSA Knee System
K182964 · Orthosoft Inc. (d/b/a) Zimmer CAS · Jan 2019
Choice Spine Navigation System
K182721 · Choicespine, LP · Jan 2019