Cleared Traditional

Paradigm System (K222291) - FDA 510(k) Clearance

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

K222291 · Proprio, Inc. · Orthopedic device
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Apr 2023
Decision
263d
Days
Class 2
Risk

K222291 is an FDA 510(k) clearance for the Paradigm 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 Proprio, Inc. (Seattle, US). The FDA issued a Cleared decision on April 21, 2023 after a review of 263 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 Proprio, Inc. devices

Submission Details

510(k) Number K222291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2022
Decision Date April 21, 2023
Days to Decision 263 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
141d slower than avg
Panel avg: 122d · This submission: 263d
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 K222291.
Excella Navigation Instruments
K223511 · Innovasis, Inc. · May 2023
CoreLink Navigation Instruments
K230880 · Corelink, LLC · May 2023
TMINI™ Miniature Robotic System
K230202 · THINK Surgical, 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
ROSA® Knee System
K230243 · Orthosoft D/B/A Zimmer Cas · Mar 2023