Cleared Traditional

K170937 - VIPER PRIME navigated inserter

K170937 is the FDA 510(k) clearance for VIPER PRIME navigated inserter by Medos International SARL. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K170937 · Medos International SARL · Orthopedic device
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Sep 2017
Decision
168d
Days
Class 2
Risk

K170937 is an FDA 510(k) clearance for the VIPER PRIME navigated inserter. 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 September 14, 2017 after a review of 168 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 Medos International SARL devices

Submission Details

510(k) Number K170937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2017
Decision Date September 14, 2017
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
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 Synthes
Laura Bleyendaal

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 365
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K170937.
iFuse Implant System- iFuse Navigation
K172268 · SI-BONE, Inc. · Oct 2017
Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
K172034 · Stryker Corporation · Oct 2017
Mako Total Knee Application
K172219 · Mako Surgical Corp. · Sep 2017
EXCELSIUS GPS
K171651 · Globus Medical, Inc. · Aug 2017
Mako Partial Knee Application
K170891 · Mako Surgical Corp. · May 2017
Mako Total Knee Application
K170581 · Mako Surgical Corp. · May 2017