Cleared Traditional

K202769 - VELYS Robotic-Assisted Solution

K202769 is the FDA 510(k) clearance for VELYS Robotic-Assisted Solution by Depuy Ireland UC. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K202769 · Depuy Ireland UC · Orthopedic device
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Jan 2021
Decision
115d
Days
Class 2
Risk

K202769 is an FDA 510(k) clearance for the VELYS™ Robotic-Assisted Solution. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Depuy Ireland UC (Ringaskiddy, Co. Cork, IE). The FDA issued a Cleared decision on January 14, 2021 after a review of 115 days - within the typical 510(k) review window.

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 Depuy Ireland UC devices

Submission Details

510(k) Number K202769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2020
Decision Date January 14, 2021
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K202769.
Erisma LP Navigated Instruments
K202956 · Clariance, Sas · Feb 2021
Practical Navigation Surgical Guidance System (PNSGS)
K202184 · Practical Navigation, LLC · Feb 2021
RESPONSE Navigation Instruments
K203573 · OrthoPediatrics Corp. · Feb 2021
ChoiceSpine Navigation System
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CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System
K202320 · Brainlab AG · Dec 2020
ADAPT for Gamma3
K202749 · Stryker GmbH · Dec 2020