Cleared Traditional

K191709 - V-STRUT Vertebral Implant

K191709 is the FDA 510(k) clearance for V-STRUT Vertebral Implant by Hyprevention Sas. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K191709 · Hyprevention Sas · Orthopedic device
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Mar 2020
Decision
253d
Days
Class 2
Risk

K191709 is an FDA 510(k) clearance for the V-STRUT Vertebral Implant. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Hyprevention Sas (Pessac Cedex, FR). The FDA issued a Cleared decision on March 5, 2020 after a review of 253 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Hyprevention Sas devices

Submission Details

510(k) Number K191709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2019
Decision Date March 05, 2020
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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

Hyprevention, Inc.
Cecile Vivez Vienney

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 - NDN Cement, Bone, Vertebroplasty

All 44
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K191709.
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