Cleared Traditional

ROSA® Knee System (K230243) - FDA 510(k) Clearance

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

K230243 · Orthosoft D/B/A Zimmer Cas · Orthopedic device
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Mar 2023
Decision
58d
Days
Class 2
Risk

K230243 is an FDA 510(k) clearance for the ROSA® Knee 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 Orthosoft D/B/A Zimmer Cas (Montreal, CA). The FDA issued a Cleared decision on March 29, 2023 after a review of 58 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 Orthosoft D/B/A Zimmer Cas devices

Submission Details

510(k) Number K230243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2023
Decision Date March 29, 2023
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K230243.
Paradigm System
K222291 · Proprio, Inc. · Apr 2023
Anatase Spine Surgery Navigation System
K230783 · Remex Medical Corp. · Apr 2023
Mazor X System (Mazor X Stealth Edition)
K230064 · Mazor Robotics , Ltd. · Apr 2023
ATEC Lateral Navigation Instruments
K223765 · Alphatec Spine, Inc. · Mar 2023
Remi Robotic Navigation System
K223350 · Fusion Robotics, LLC · Mar 2023
PathKeeper System
K222355 · Pathkeeper Surgical , Ltd. · Mar 2023