Cleared Traditional

TELIGEN System Navigation Ready Instruments (K233254) - FDA 510(k) Clearance

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

K233254 · DePuy Synthes · Orthopedic device
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Jun 2024
Decision
260d
Days
Class 2
Risk

K233254 is an FDA 510(k) clearance for the TELIGEN System Navigation Ready Instruments. 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 Synthes (Oberdor, CH). The FDA issued a Cleared decision on June 14, 2024 after a review of 260 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 DePuy Synthes devices

Submission Details

510(k) Number K233254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date June 14, 2024
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
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 K233254.
CROSSNAV Navigation Enabled Instruments
K233255 · DePuy Synthes · Jun 2024
Robotic Integration Instruments
K233256 · DePuy Synthes · Jun 2024
Spine Navigation and Robotic-Assistance Device
K233228 · Ecential Robotics · Jun 2024
ExcelsiusFlex™
K240721 · Globus Medical, Inc. · Jun 2024
INNOVERSE Navigation Instruments
K241082 · Innosys Co., Ltd. · Jun 2024
Mako Total Knee Application
K241011 · Mako Surgical Corp. · Jun 2024