Cleared Traditional

Paradigm System (K250879) - FDA 510(k) Clearance

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

K250879 · Proprio, Inc. · Orthopedic device
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Jun 2025
Decision
72d
Days
Class 2
Risk

K250879 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 June 4, 2025 after a review of 72 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 Proprio, Inc. devices

Submission Details

510(k) Number K250879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2025
Decision Date June 04, 2025
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 K250879.
TMINI Miniature Robotic System
K250877 · THINK Surgical, Inc. · Jun 2025
SPINEART Navigation Instrument System
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Stealth™ Spine Clamps
K242464 · Medtronic Navigation, Inc. · Jun 2025
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
K251315 · Remex Medical Corp. · May 2025
OTS Hip
K250086 · Ortoma AB · May 2025
Altus Spine Navigation System
K243419 · Altus Partners, LLC · May 2025