Cleared Traditional

Small VBR™ (K192117) - FDA 510(k) Clearance

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

K192117 · Ulrich GmbH & Co. KG · Orthopedic device
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Nov 2019
Decision
87d
Days
Class 2
Risk

K192117 is an FDA 510(k) clearance for the Small VBR™. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on November 1, 2019 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ulrich GmbH & Co. KG devices

Submission Details

510(k) Number K192117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2019
Decision Date November 01, 2019
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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

Ulrich Medical USA
Hans Stover

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 - MQP Spinal Vertebral Body Replacement Device

All 276
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K192117.
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KONG®-TL VBR System and KONG® C VBR System
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DOMINION Expandable Corpectomy System
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VerteLoc Spinal System
K231134 · Signature Orthopaedics Pty, Ltd. · Feb 2024
Ascend VBR System, Ascend NanoTec VBR System
K232173 · Alphatec Spine, Inc. · Oct 2023