Cleared Traditional

OMNIBotics Knee System (K200888) - FDA 510(k) Clearance

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

K200888 · Corin, Ltd. · Orthopedic device
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Jun 2020
Decision
85d
Days
Class 2
Risk

K200888 is an FDA 510(k) clearance for the OMNIBotics 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 Corin, Ltd. (Raynham, US). The FDA issued a Cleared decision on June 27, 2020 after a review of 85 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 Corin, Ltd. devices

Submission Details

510(k) Number K200888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2020
Decision Date June 27, 2020
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 Consultant

BioVera, Inc.
Robert A. Poggie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K200888.
Joimax Intracs System
K192663 · Joimax GmbH · Jul 2020
Mako Total Knee Application
K193515 · Mako Surgical Corp. · Jul 2020
ExcelsiusGPS Cranial 1.0 Module
K200047 · Globus Medical, Inc. · Jul 2020
Streamline Navigated Instruments
K200095 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jun 2020
Harvey(R) Surgical Assistant
K200892 · Orthalign, Inc. · Jun 2020
NavLock Trackers
K201327 · Medtronic Navigation · Jun 2020