Cleared Traditional

K223108 - TELIGEN System Navigation Ready Indicat...

K223108 is the FDA 510(k) clearance for TELIGEN System Navigation Ready Indicat... by Medos International SARL. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K223108 · Medos International SARL · Orthopedic device
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Jan 2023
Decision
111d
Days
Class 2
Risk

K223108 is an FDA 510(k) clearance for the TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Cl.... Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Medos International SARL (Lelocle, CH). The FDA issued a Cleared decision on January 19, 2023 after a review of 111 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 Medos International SARL devices

Submission Details

510(k) Number K223108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date January 19, 2023
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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

Depuy Spine
Karin McDonough

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 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K223108.
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